PROSTHESIS, PENIS, INFLATABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for PROSTHESIS, PENIS, INFLATABLE manufactured by American Medical Systems, Llc (boston Scientific).

Event Text Entries

[82593054]
Patient Sequence No: 1, Text Type: N, H10


[82593055] Patient was admitted from nursing home with a penile implant exposed, without pain or tenderness. Left cylinder of the device was extruded through the urethral meatus. Surgeon noted that it appeared as if the implant was placed through a penis/scrotal incision. Surgeon explanted both cylinders. The device appeared to be a 2-piece inflatable penile prosthesis of an unknown brand placed elsewhere years ago. There was a corporal defect just inside the meatus from the eroded implant. Meatus wound was irrigated, but not closed because the patient has a suprapubic tube, which was changed during the same surgery. Penis scrotal wound was closed. Patient tolerated the procedure and there were no complications. Patient was discharged to nursing home on post-op day 2 in stable condition. Manufacturer response for inflatable penile prosthesis, (per site reporter): manufacturer will investigate the cause when the device is returned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6791364
MDR Report Key6791364
Date Received2017-08-14
Date of Report2017-08-07
Date of Event2017-08-02
Report Date2017-08-07
Date Reported to FDA2017-08-07
Date Reported to Mfgr2017-08-07
Date Added to Maude2017-08-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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

Generic NamePROSTHESIS, PENIS, INFLATABLE
Product CodeJCW
Date Received2017-08-14
Returned To Mfg2017-08-08
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS, LLC (BOSTON SCIENTIFIC)
Manufacturer Address10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-14

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