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 2019-05-15 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.

Event Text Entries

[145124837] (b)(4). The facility has communicated that the device is not available for investigation. A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production p/n dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot# 73e1900056, the samples were functionally inspected, and issue reported as rubber bands breaking was not observed in the current manufacturing process. The device history reviews the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg lot# 73k1800935 investigation did not show issues related to the complaint. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect. At this time since the sample is not available it is not possible to determine the source of the defect reported. The customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and to determine the root cause. If the alleged defect samples become available at a later date, this complaint will be updated accordingly. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[145124838] It was reported that the elastic is breaking.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2019-00596
MDR Report Key8612287
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-15
Date of Report2019-05-01
Date of Event2019-03-19
Date Mfgr Received2019-05-01
Device Manufacturer Date2018-10-31
Date Added to Maude2019-05-15
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 ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
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-POWE
Product CodeHAO
Date Received2019-05-15
Catalog Number382805
Lot Number73K1800935
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-15

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