MAUDE Adverse Event Report: TELEFLEX MEDICAL DURAHOOK 1/4 HOOK; INSTRUMENT,SURGICAL,NON-POWERED

Catalog Number 382800

Device Problems Break (1069); Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history reviews for the product durahook 1/4 hook 10 pkg/bx 6 hks/pkg, lot number 73d1500050 investigations did not show issues related to the complaint.The device sample has not been returned for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the item is discolored and breaks when stretched.The patient's condition was reported as fine.

• Brand Name: DURAHOOK 1/4 HOOK
• Type of Device: INSTRUMENT,SURGICAL,NON-POWERED
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5138454
• MDR Text Key: 28075474
• Report Number: 3003898360-2015-00731
• Device Sequence Number: 1
• Product Code: GDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2016
• Device Catalogue Number: 382800
• Device Lot Number: 73D1500050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1