MAUDE Adverse Event Report: TELEFLEX INCORPORATED WECK; STAPLE, REMOVABLE (SKIN)

Model Number IPN028493

Device Problem Difficult to Open or Close (2921)

Patient Problem Wound Dehiscence (1154)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

Surgeon states product has resulted in three patients having staples that have fallen out.One patient required multiple steri strips layers to prevent the wound from opening further.He further states that he has 2 other patients with closure issues, the last was seen in his office and resulted in a 3 cm opening in the incision.

• Brand Name: WECK
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 35 innovation way; wyomissing PA 19610
• MDR Report Key: 16806087
• MDR Text Key: 313912020
• Report Number: 16806087
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2023,03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028493
• Device Catalogue Number: 528235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2023
• Date Report to Manufacturer: 04/25/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Female