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

Model Number NON250412

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Infection (4544)

Event Date 04/18/2023

Event Type  Injury  

Event Description

Skin trauma requiring antibiotics.

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
• Type of Device: 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
• MDR Text Key: 315909818
• Report Number: 1417592-2023-00233
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 20080196691927
• UDI-Public: 20080196691927
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other