LCS HP PAT RES GUIDE 9505-01-122 950501122

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-05 for LCS HP PAT RES GUIDE 9505-01-122 950501122 manufactured by Depuy International Ltd - 8010379.

Event Text Entries

[182376442] Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: examination of the returned device could not confirm the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10


[182376443] It was reported that the instrument won't open completely and it sticks. Found when set returned to the office for inspection. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06988
MDR Report Key9794427
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-05
Date of Report2020-02-18
Date of Event2020-02-18
Date Mfgr Received2020-02-18
Device Manufacturer Date2009-03-15
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLCS HP PAT RES GUIDE
Generic NameKNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Product CodeFSM
Date Received2020-03-05
Returned To Mfg2020-02-25
Model Number9505-01-122
Catalog Number950501122
Lot NumberJ0309
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY INTERNATIONAL LTD - 8010379
Manufacturer AddressST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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