FDA.reportPublic FDA data

MAUDE MDR 6534610

MDR report key
6534610
Report number
3003898360-2017-00403
Event key
0
Event type
3
Date of event
2017-03-30
Date received
2017-05-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JASMINE BROWN
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9193
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKGINSTRUMENT,SURGICAL,NON-POWEREDTELEFLEX MEDICALHAO38280573K1600692N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-010

Event Narratives#

N

Patient 1

(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DERMAHOOK 1/2 HOOKS 10 PKG/BX 6 HKS/PKG, LOT #73K1600692 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

D

Patient 1

THE ELASTIC BROKE DURING USE ON 3 DIFFERENT HOOKS. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN AT THIS TIME.

N

Patient 1

(B)(4). THE CUSTOMER RETURNED ONE UNIT OF 382805 DERMAHOOK 1/2 HOOK PKG/BX 6 HKS/PKG FOR INVESTIGATION. ONLY ONE HOOK AND SUTURE THREAD WAS RETURNED. NO TPE BANDS WERE RETURNED. THE SAMPLE WAS RETURNED WITHOUT ITS ORIGINAL PACKAGING. THE RETURNED SAMPLE WAS VISUALLY INSPECTED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. THE HOOK AND SUTURE THAT WAS RETURNED APPEARS TO BE INTACT. SINCE THE TPE BAND WAS NOT RETURNED, IT COULD NOT BE DETERMINED HOW IT BROKE OFF FROM THE HOOK AND SUTURE. REFERENCE FILES (B)(4) FOR INVESTIGATION PHOTOS. SINCE THE TPE BAND WAS NOT RETURNED, IT COULD NOT BE CONFIRMED THAT IT BROKE. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE REPORTED COMPLAINT OF "BROKEN" COULD NOT BE CONFIRMED SINCE THE TPE BAND WAS NOT RETURNED. ONLY THE HOOK AND SUTURE WERE RETURNED AND BOTH APPEARED TO BE COMPLETELY INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. SINCE THE TPE BAND WAS NOT RETURNED, IT COULD NOT BE CONFIRMED THAT IT BROKE. NO FURTHER ACTION WILL BE TAKEN.

D

Patient 1

THE ELASTIC BROKE DURING USE ON 3 DIFFERENT HOOKS. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN AT THIS TIME.