MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0900 - AQUACEL AG; DRESSING, WOUND, DRUG

Model Number	412011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by end user¿s wife that aquacel ag surgical dressing was applied to the end user¿s left knee incision on sixth of (b)(6) 2021 and within one day, redness started at incision site and radiated to groin and to ankle.However, according to the photos received, it appeared that the redness extended toward ankle and did not extend to groin.The end user was started on penicillin prescribed.The dressing was removed on tenth of (b)(6) 2021 and discontinued to use.By thirteenth of (b)(6) 2021, redness had completely resolved.Photograph depicting the issue was received from the complainant.

• Brand Name: L3W0900 - AQUACEL AG
• 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: 13801262
• Report Number: 9618003-2022-00258
• Device Sequence Number: 11718039
• Product Code: FRO
• UDI-Device Identifier: 00768455124299
• UDI-Public: 00768455124299
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: Lay User/Patient
• Device Model Number: 412011
• Device Catalogue Number: 412011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/17/2022
• 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: Male