MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MDSM611550

Catalog Number	MDSM611550
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Blister (4537)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the adhesive caused oozing blisters.Due to this "antibiotics and antihistamines" were prescribed.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Blisters from adhesive.

• Common Device Name: MDSM611550
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19544939
• Report Number: 1417592-2024-00657
• Device Sequence Number: 17844091
• Product Code: DRX
• UDI-Device Identifier: 40884389830346
• UDI-Public: 40884389830346
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2024

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
• Device Catalogue Number: MDSM611550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 74 KG