CUSTOM ELBOW V 2944-9-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-10 for CUSTOM ELBOW V 2944-9-101 manufactured by Howmedica, Inc..

Event Text Entries

[3557] Chronic dislocation and deep wound infection. All implants removed. Fair. Device labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number33448-1993-00141
MDR Report Key7041
Date Received1993-11-10
Date of Report1993-10-04
Date of Event1993-09-15
Date Facility Aware1993-10-01
Report Date1993-10-04
Date Reported to FDA1993-10-04
Date Reported to Mfgr1993-10-04
Date Added to Maude1993-11-30
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCUSTOM ELBOW V
Generic NameSOUTER CUSTOM ELBOW
Product CodeKWJ
Date Received1993-11-10
Catalog Number2944-9-101
Lot NumberLZPZD
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant FlagY
Device Sequence No1
Device Event Key6724
ManufacturerHOWMEDICA, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-11-10

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