File a product complaint

Thank you for choosing to report a product complaint. Your feedback is essential for maintaining the quality, safety and performance of our products. Please follow the instructions below when submitting your complaint via email to complaints@abigo.com

• Reporter’s information (name, address, email address, phone number, country).
• Information about the affected person, if different from the reporter (name, address, email address, phone number, country).
• Organization information, if applicable (organization name, internal complaint number).
• Product information (product name, product reference number, batch/LOT number, manufacturing date, expiry date, UDI if available).
• Affected quantities. Please specify which item is affected (device/dressing, primary packaging/pouch, secondary packaging/carton).
• Awareness date and date when the event occurred.
• Has the product been used?
• Description of the problem. (Please describe the issue as clearly and detailed as possible, including the product defect and/or clinical signs as applicable. The information will be kept strictly confidential).
• Was any user or patient affected by any harm, injury, discomfort, irritation or other health-related effects by this event? If yes, please describe the reaction, where it occurred, any medical treatment received, any known allergies, and the current status of the patient/user.
• Please describe how the product was used (e.g. where on the body it was used, how it was applied, how long it was used before the issue occurred, and whether any other products were used at the same time).
• Product status (available, used, contaminated, discarded).
• Attach photographs or video of the event (the product defect and/or the clinical sign). If possible, also attach photographs of the product packaging and labeling showing the UDI, batch/LOT number, manufacturing date and expiry date.
• Are samples available?
• Do you wish to get a reply on this complaint? If yes, please make sure you have filled out your contact information.

Thank you for your cooperation. We appreciate your commitment to product safety and quality.