MAUDE Adverse Event Report: Medline Industries, LP PRIVATE LABELED FOR CUSTOMER; BNDG,ANTIBAC,ADHSV PAD,SHEER,2X3,10CT

Catalog Number	WRX940858V2
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "skin irritation" occurred and "my stomach was red where the band aid had been.".
Additional Manufacturer Narrative
The customer reported that after the bandage was applied to the belly button area for approximately 3-4 hours, ¿it felt like my stomach had a burn on it,¿ the stomach was red where the band aid had been, and ¿the burn had started to scab.¿ the provided photos were reviewed, the provided sample was evaluated, the vendor was notified of the issue, and trend analysis was performed; photos showed signs of irritation and redness where the bandage was applied, and the received bandages were visually inspected with no visual defects noted.Based on the information provided and the results of the investigation, the reported issue was confirmed, however, it could not be confirmed that the product failed to meet specifications.The vendor noted no indications of potential causes to the reported issue, biocompatibility was evaluated and verified in accordance with iso 10993 with no biological safety nonconformances identified, no product defect was confirmed, and the product will continue to be monitored through routine complaint trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: PRIVATE LABELED FOR CUSTOMER
• Common Device Name: BNDG,ANTIBAC,ADHSV PAD,SHEER,2X3,10CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884862
• Report Number: 1417592-2026-50080
• Device Sequence Number: 15909156
• Product Code: FRO
• UDI-Device Identifier: 00311917185026
• UDI-Public: 00311917185026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: WRX940858V2
• Device Lot Number: 241204
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown