DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-01 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.

Event Text Entries

[74101437] (b)(4). The device history review for the product dermahook 1/2 hook 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.
Patient Sequence No: 1, Text Type: N, H10


[74101438] The elastic broke during use on 3 different hooks. The patient's condition was reported as unknown at this time.
Patient Sequence No: 1, Text Type: D, B5


[76649829] (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.
Patient Sequence No: 1, Text Type: N, H10


[76649830] The elastic broke during use on 3 different hooks. The patient's condition was reported as unknown at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2017-00404
MDR Report Key6534635
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-05-01
Date of Report2017-04-04
Date of Event2017-03-30
Date Mfgr Received2017-05-19
Device Manufacturer Date2016-10-25
Date Added to Maude2017-05-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
Generic NameINSTRUMENT,SURGICAL,NON-POWERED
Product CodeHAO
Date Received2017-05-01
Returned To Mfg2017-04-19
Catalog Number382805
Lot Number73K1600692
Device Expiration Date2018-04-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-01

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