AMS MS GENIAL IMPLANT AMS 700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for AMS MS GENIAL IMPLANT AMS 700 manufactured by American Medical Systems, Inc..

MAUDE Entry Details

Report NumberMW5088503
MDR Report Key8842800
Date Received2019-07-29
Date of Report2019-07-25
Date of Event2019-04-23
Date Added to Maude2019-07-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameAMS MS GENIAL IMPLANT
Generic NamePROSTHESIS, PENIS, INFLATABLE
Product CodeJCW
Date Received2019-07-29
Model NumberAMS 700
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.

Device Sequence Number: 2

Brand NameAMS MS GENIAL IMPLANT
Generic NamePROSTHESIS, PENIS, INFLATABLE
Product CodeJCW
Date Received2019-07-29
Model NumberAMS 700
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-29

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