MAUDE Adverse Event Report: TELEFLEX MEDICAL DERMAHOOK 1/2 HOOK

Catalog Number 382805

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Event Description

Alleged event: the elastics are shredding and they are very thin.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot number 73c1500433 did not show issues related to the complaint.The manufacturer will continue to monitor and trend related events.

• Brand Name: DERMAHOOK 1/2 HOOK
• 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: 4951977
• MDR Text Key: 6636506
• Report Number: 3003898360-2015-00551
• 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: 09/27/2016
• Device Catalogue Number: 382805
• Device Lot Number: 73C1500433
• Was Device Available for Evaluation?: No
• 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: 03/24/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1