MAUDE Adverse Event Report: SHANGHAI ISO MEDICAL PRODUCTS CO. LTD MCKESSON BRANDS; CLOSURE, SKIN FLEX LF TAN 1X5"

Catalog Number 3005

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/09/2023

Event Type  Injury  

Event Description

It was reported by the customer that the skin closure strips have caused 4 patient reactions in the last two weeks.Two breast incisions, one tummy tuck incision, and one submental neck incision.Patients are experiencing redness, irritation and wound "breakdown".

• Brand Name: MCKESSON BRANDS
• Type of Device: CLOSURE, SKIN FLEX LF TAN 1X5"
• Manufacturer (Section D): SHANGHAI ISO MEDICAL PRODUCTS CO. LTD; 999 liu chen rd.; pudong, shanghai 20120 2; CH 201202
• MDR Report Key: 17243420
• MDR Text Key: 318285870
• Report Number: 1451040-2023-00032
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

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 Operator: Health Professional
• Device Catalogue Number: 3005
• Device Lot Number: CIOB08-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2023
• Distributor Facility Aware Date: 06/09/2023
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other