PROCARE 79-96820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for PROCARE 79-96820 manufactured by Djo, Llc.

MAUDE Entry Details

Report Number9166642
MDR Report Key9166642
Date Received2019-10-08
Date of Report2019-09-12
Date of Event2019-04-23
Report Date2019-09-12
Date Reported to FDA2019-09-12
Date Reported to Mfgr2019-10-08
Date Added to Maude2019-10-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROCARE
Generic NameSLEEVE, LIMB, COMPRESSIBLE
Product CodeJOW
Date Received2019-10-08
Catalog Number79-96820
Lot Number00000
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.