MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BANDAGE,ANTIBAC,FLEX FABRIC,XL,10CT

Catalog Number	WRX940856V1
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the end-user experienced a skin reaction to her left chest after leaving the bandage on for three (3) days over her implanted chemotherapy port.It was not identified if the skin reaction was experienced on skin in contact with the bandage pad or the bandage adhesive.Reportedly, the end-user experienced "blistering pustules," the chemotherapy port was unable to be accessed for chemotherapy treatment, and the end-user was prescribed and unidentified antibiotic.According to the end-user her oncologist informed her that she experienced "a dermatitis response to the site." no additional medical intervention or follow-up care was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention, 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 during use of the bandage and antibiotic treatment was required.
Additional Manufacturer Narrative
A box of wrx940856v1 bandages was returned to the manufacturer for evaluation.Multiple bandages were evaluated and no issues were noted with the adhesive.Bandages were applied to intact skin and no issues were noted at the application site.Although a root cause for the reported incident was unable to be determined, variable conditions such as temperature, humidity, and length of wear may affect the bandage and cause the reported issue experienced by the end-user.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: BANDAGE,ANTIBAC,FLEX FABRIC,XL,10CT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9192001
• Report Number: 1417592-2019-00168
• Device Sequence Number: 11677542
• Product Code: FRO
• UDI-Device Identifier: 00311917185002
• UDI-Public: 00311917185002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: Lay User/Patient
• Device Catalogue Number: WRX940856V1
• Device Lot Number: 18111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 66