MAUDE Adverse Event Report: PRIMECARE MEDICAL (SUZHOU) 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
Additional Manufacturer Narrative
The manufacturer has conducted appearance test and performance testing on the returned sample, and the test results are qualified; no phenomenon described in the report was found during simulated use.In addition, the manufacturer randomly selected 5 samples from the retained samples of the same lot for testing, and these samples also passed the tests.Dhr for product cze06-02 was reviewed.No deviations were identified during the production process, including in-process and finished product inspections.All product inspections were found acceptable.This product is for prescription use only, and the event location is home, which is expected to be caused by incorrect use methods.
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): PRIMECARE MEDICAL (SUZHOU) CO.,LTD.; bldg a1/a4, no. 2 zengfu rd; guli development zone; changshu, jiangsu 21553 2; CH 215532
• Manufacturer Contact: qing yan ; bldg a1/a4, no. 2 zengfu rd; guli development zone; changshu, jiangsu 21553-2 ; CH 215532
• MDR Report Key: 24813881
• Report Number: 3015337348-2026-00001
• Device Sequence Number: 5952193
• Product Code: MCZ
• UDI-Device Identifier: 10612479205892
• UDI-Public: 10612479205892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown