MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL AG+/AAA SURGICAL; DRESSING, WOUND, DRUG

Model Number	422605
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Name of retailer/dealer/distributor affiliation: (b)(6).This information in the emdr was reported by the doctor to the distributor representatives and then these representatives in turn reported the information to the company¿s employee.This emdr is being submitted since based on review of photo, harm was identified as a serious injury and the cause for harm and product malfunction could not be determined.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).
Event or Problem Description
It was reported that removal of one dressing out of market unit box of dressings "stripped" the peri-wound skin causing it to look "irritated" to one side of the incision which might be a knee incision.The product was used on patient by an orthopedic surgeon who was new to product.The doctor asked if the issue was due an allergic reaction to the company¿s product on the dressing however the issue did not occur everywhere but appears to be primarily to one side of the incision.One would not expect this pattern if it were an allergic reaction.It was reported that it appeared that perhaps the dressing in use was too small for the incision which would have necessitated stretching the dressing to fit the wound causing tension on the peri-wound area.It was unknown how long the dressing was in place, what angle the appendage was when the dressing was applied, or if any products were used to the skin under the dressing.It was not confirmed if the dressing was difficult to remove from the skin.The patient was not hospitalized regarding the issue.No outcome information was available, and it was unknown if the same dressing was re-applied.Photographs associated with the issue were received from the complainant.

• Brand Name: AQUACEL AG+/AAA SURGICAL
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 16110671
• Report Number: 9618003-2023-00042
• Device Sequence Number: 6839490
• Product Code: FRO
• UDI-Device Identifier: 00768455169542
• UDI-Public: 768455169542
• Combination Product (Y/N): N
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: Health Professional
• Device Model Number: 422605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown