MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. WALGREENS; BANDAGE,ANTIBAC,ADHSV PAD,SHEER,3X4,10CT

Model Number	940859
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the end-user experienced a skin reaction to the bandage adhesive during product use.The bandage was applied to the end-user's shin.The skin reaction was reportedly "nearly a perfect rectangle shape of the bandage" and was noted to be discolored and peeling.The end-user was evaluated by a physician and received unspecified medical treatment.No specific diagnoses or further medical treatment and/or follow-up care was reported.No sample has been returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined at this time.Due to the reported need for unspecified medical treatment, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the end-user experienced a skin reaction to the bandage adhesive during product use.
Additional Manufacturer Narrative
A sample was returned to the manufacturer and evaluation has been completed.No differences between the returned sample and samples pulled from inventory were identified.A root cause was not identified, however, variable conditions during wear such as temperature, humidity, and length, may affect the bandage and adhesive and may cause or contribute to the reported issue experienced by the end-user.If additional relevant information becomes available another supplemental medwatch will be filed.

• Brand Name: WALGREENS
• Common Device Name: BANDAGE,ANTIBAC,ADHSV PAD,SHEER,3X4,10CT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11825616
• Report Number: 1417592-2021-00092
• Device Sequence Number: 4242538
• Product Code: FRO
• UDI-Device Identifier: 00311917185033
• UDI-Public: 00311917185033
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 940859
• Device Catalogue Number: WRX940859V1
• Device Lot Number: 19112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: Required Intervention