AUTO SUTURE PREMIUM EXTRACTOR 150462 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-30 for AUTO SUTURE PREMIUM EXTRACTOR 150462 * manufactured by Us Surgical Corp.

Event Text Entries

[266882] Staples to be removed from c/s pt. Staff obtained auto suture premium extractor, a single use skin staple remover and attempted staple removal. The staff member was unable to get at the staples without digging into the pt's incision with the prongs. Pt was very uncomfortable and in tears during the removal of staples. Staff member was very dissatisfied with the product. Believes the prongs are very sharp - too sharp. This facility will be switching to a different brand of staple remover which is rounded on the bottom which prevents it from digging into the pt's skin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026608
• MDR Report Key: 425685
• Date Received: 2002-10-30
• Date of Report: 2002-10-24
• Date of Event: 2002-10-05
• Date Added to Maude: 2002-11-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AUTO SUTURE PREMIUM EXTRACTOR
• Generic Name: STAPLE REMOVER
• Product Code: MCZ
• Date Received: 2002-10-30
• Model Number: 150462
• Catalog Number: *
• Lot Number: P2E893
• ID Number: EXP 2007-06
• Device Expiration Date: 2007-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 414736
• Manufacturer: US SURGICAL CORP
• Manufacturer Address: 150 GLOVER AVE NORWALK CT 068565080 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-10-30