MAUDE Adverse Event Report: ALLMED MEDICAL PRODUCTS CO., LTD. HENRY SCHEIN; BANDAGE ADHESIVE STRIP FABRIC LF 1" X 3"

Catalog Number 112-6133

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peeling (1999)

Event Date 02/28/2024

Event Type  Injury  

Event Description

A male patient reported directly that he had a small one-eighth inch wound and the bandaid was placed on it.Upon removal of the bandaid the wound got bigger as the glue was too strong peeling some of the skin from his hand.He has since applied a gauze.

• Brand Name: HENRY SCHEIN
• Type of Device: BANDAGE ADHESIVE STRIP FABRIC LF 1" X 3"
• Manufacturer (Section D): ALLMED MEDICAL PRODUCTS CO., LTD.; no. 99 jin shan road; majiadian town; zhijiang city, hubei 44320 0; CH 443200
• MDR Report Key: 18952684
• MDR Text Key: 338270801
• Report Number: 2411236-2024-00003
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

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 Operator: Lay User/Patient
• Device Catalogue Number: 112-6133
• Device Lot Number: A34722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2024
• Distributor Facility Aware Date: 02/28/2024
• Event Location: Home
• Date Report to Manufacturer: 03/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male