MAUDE Adverse Event Report: CONOD MEDICAL CO., LTD MCKESSON BRANDS; STAPLE REMOVER TRAY, SKIN W/PREP

Catalog Number	241
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that when attempting to remove staple, the pliers crimped the staple and pushed it downward into the skin instead of lifting it outward.Patient did have to go into surgeon's office to get the staples removed after they became bowed and remained in the skin.

• Brand Name: MCKESSON BRANDS
• Common Device Name: STAPLE REMOVER TRAY, SKIN W/PREP
• Manufacturer (Section D): CONOD MEDICAL CO., LTD; no. 38 hongfeng road; baimao industrial park; changshu, jiangsu 21553 2; CH 215532
• MDR Report Key: 23990722
• Report Number: 1451040-2026-00001
• Device Sequence Number: 16082860
• Product Code: PYE
• UDI-Device Identifier: 10612479205892
• UDI-Public: 10612479205892
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2026
• Report Date (Section F): 01/07/2026

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?: Yes
• Device Catalogue Number: 241
• Device Lot Number: CZE06-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2025
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/07/2026