MAUDE Adverse Event Report: TELEFLEX MEDICAL DERMAHOOK 1/4 HOOKS

Catalog Number 382805

Device Problem Degraded (1153)

Patient Problem Not Applicable (3189)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

Alleged event: the dermahooks are dry rotting which is evident through the packaging.There was no patient involvement.

Manufacturer Narrative

(b)(4).The device history review for the product durahook 1/4 hooks 10 pkg/bx 6 hks/pkg, lot number 73k1400269 did not show issues related to the complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

• Brand Name: DERMAHOOK 1/4 HOOKS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4952347
• MDR Text Key: 6192058
• Report Number: 3003898360-2015-00539
• Device Sequence Number: 0
• Product Code: GDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2016
• Device Catalogue Number: 382805
• Device Lot Number: 73K1400269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1