AMS 700 SPHERICAL RESERVOIR 720185-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-27 for AMS 700 SPHERICAL RESERVOIR 720185-01 manufactured by American Medical Systems, Inc..

MAUDE Entry Details

Report Number9382745
MDR Report Key9382745
Date Received2019-11-27
Date of Report2019-11-19
Date of Event2019-11-06
Report Date2019-11-19
Date Reported to FDA2019-11-19
Date Reported to Mfgr2019-11-27
Date Added to Maude2019-11-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS 700 SPHERICAL RESERVOIR
Generic NamePROSTHESIS, PENIS, INFLATABLE
Product CodeJCW
Date Received2019-11-27
Returned To Mfg2019-11-20
Model Number720185-01
Lot Number1000320682
Device AvailabilityR
Device Age0 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.
Manufacturer Address10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-27

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