MAUDE Adverse Event Report: TELEFLEX LLC SKIN STAPLER 35W; STAPLER, SKIN

Model Number	25-3001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hair Loss (1877); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported, "patient reported wound healing issues at the staple site and hair loss allegedly caused by the stapler.".
Additional Manufacturer Narrative
A user facility reported, "patient reported wound healing issues at the staple site and hair loss allegedly caused by the stapler." deroyal industries, inc.Requested return of the device, but it was stated it was not available for return.A supplier corrective action request (scar) will be issued to the supplier/manufacturer, teleflex llc.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Additional Manufacturer Narrative
A user facility reported, "patient reported wound healing issues at the staple site and hair loss allegedly caused by the stapler." deroyal industries, inc.Requested return of the device, but it was stated it was not available for return.Because the lot number was not provided, the work order was not able to be reviewed.An inventory check was performed on a box retained at deroyal and found to be acceptable.The risk analysis was not reviewed as this is a purchased item and deroyal does not own the risk documentation.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).A supplier corrective action request (scar) will be issued to the supplier/manufacturer, teleflex llc.The supplier reported that they were unable to perform a full investigation because the sample nor the lot were provided.Root cause: the root cause was unable to be determined because the sample nor the lot were provided and therefore no specific investigation was able to be performed.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: SKIN STAPLER 35W
• Common Device Name: STAPLER, SKIN
• Manufacturer (Section D): TELEFLEX LLC; 2917 weck drive; durham NC 27709 0186
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23876852
• Report Number: 1060680-2025-00056
• Device Sequence Number: 13174221
• Product Code: QQS
• UDI-Device Identifier: 00749756024372
• UDI-Public: 00749756024372
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 25-3001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown