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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL DERMAHOOK 1/2 HOOK Back to Search Results
Catalog Number 382805
Device Problem Degraded
Event Date 08/11/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot number 73c1500433 investigation did not show issues related to 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 elastics are shredding. The issue was identified prior to patient involvement.

 
Manufacturer Narrative

(b)(4). Twelve (12) pouches from p/n 382805 dermahook 1/2 hook 10 pkg/bx 6 hks/pkg were received not used, closed in original packaging; lot # 73c1500433 was confirmed with received pouches, during visual inspection it was observed that 12 samples were received inside a bag. Components looked well assembled; rubber bands did not appear to have damage. Failure mode elastics shredding/deterioration reported by the customer was not confirmed during visual inspection. The 12 pouches were opened to review the rubber bands conditions and no issues were found (not broken & no deterioration. Based on samples (12 pouches) inspection the failure modes elastics shredding/deterioration reported by the customer was not confirmed with received samples during visual inspection; rubber bands without damage, therefore at this time no corrective actions will be taken.

 
Event Description

Alleged event: the elastics are shredding. The issue was identified prior to patient involvement.

 
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Brand NameDERMAHOOK 1/2 HOOK
Type of DeviceDERMAHOOK
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 Key5043177
Report Number3003898360-2015-00596
Device Sequence Number1
Product CodeHAO
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 08/12/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/27/2016
Device Catalogue Number382805
Device LOT Number73C1500433
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/22/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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