MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; STRIP,CLOSURE,WOUND,MEDI-STRIP,1/2X4

Model Number	NON250412
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Skin trauma requiring antibiotics.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 "steri strips applied to breast incision following delayed diep flap reconstruction" on the right breast.It was reported the device was in place for one week and "skin trauma" occurred which was described as "blistered, epidermolysis".Due to the reported incident, the patient required antibiotic ointment and frequent outpatient follow up.A sample was requested to be returned for evaluation.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.

• Brand Name: Medline
• Common Device Name: STRIP,CLOSURE,WOUND,MEDI-STRIP,1/2X4
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16997551
• Report Number: 1417592-2023-00233
• Device Sequence Number: 17888572
• Product Code: KGX
• UDI-Device Identifier: 20080196691927
• UDI-Public: 20080196691927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

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 Model Number: NON250412
• Device Catalogue Number: NON250412
• Device Lot Number: 47129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown