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

Qn#(b)(4).The device history review for the dermahook 1/2 hook 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.

Manufacturer Narrative

(b)(4).One (1) pouch from p/n 382805 dermahook 1/2 hook (b)(4) was received not used, closed in original packaging, lot # 73k1400269 was confirmed.During visual inspection it was observed that the rubber bands were deteriorated.Failure mode dry rot reported by the customer was confirmed during visual inspection.Samples received confirm the defect reported by the customer "dry rot." a review was conducted of the ifu and it was found that the customer is directed to "inspect each durahook and dermahook prior to use, specifically to ensure the integrity of the elastic band.If the elastic band contains tears, splits or other damage, do not use." in addition, this defect was found before to use in the patient.Therefore a corrective action is not required at this time.However we will continue to monitor trending of similar complaints.

Event Description

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

• Brand Name: DERMAHOOK 1/4 HOOKS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4952548
• MDR Text Key: 6037904
• Report Number: 3003898360-2015-00543
• 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,company representati
• Reporter Occupation: Other
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2015
• 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