MAUDE Adverse Event Report: ABIGO MEDICAL AB SORBACT GEL DRESSING; DRESSING, WOUND, DRUG

Model Number	7.5X7.5 CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Burning Sensation (2146)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter an epidermal inflammatory reaction and enlargement of ulcerous lesions was observed after 21 days of treatment of a wound with sorbact gel dressing.Sorbact gel dressing was covered with a wet compress and maintained by resposorb during treatment.Burning sensation and pain was also reported.No fever.Hospitalization was required.After stop using sorbact gel dressing the inflammatory reaction was amplified during 3 days and thereafter stopped.The sorbact gel dressing was changed daily during treatment.Many gel dressings (no information on the number of products) were applied on the venous ulcer which covered a large part of the calf and tibia.The venous ulcer was very diffuse so products were not applied only to the wound but also to the surrounding skin.No cream or gels were used simultaneously but a compression with urgok2 was implemented.The nurse did not follow the patient again and so she does not have more data regarding the length of hospitalization nor the patient's recovery.

• Brand Name: SORBACT GEL DRESSING
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): ABIGO MEDICAL AB; ekonomivägen 5; askim, SE-43 633; SW SE-43633
• MDR Report Key: 8599199
• Report Number: 8043991-2019-00001
• Device Sequence Number: 10739136
• Product Code: FRO
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/12/2021
• Device Model Number: 7.5X7.5 CM
• Device Catalogue Number: 98138
• Device Lot Number: 8112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR