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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404237
Device Problems Fluid Leak; Free or Unrestricted Flow
Event Date 11/14/2019
Event Type  Injury  
Manufacturer Narrative

Reservoir, model- 720185-01, lot sn- (b)(4), mfg date- 11/25/2017, exp date- 11/25/2019, gtin- (b)(4). Device not returned for analysis.

 
Event Description

It was reported that due to "penis thinning and inflated implant without axial stiffness, middle fold and empty pump. Non-functional penis," the patient will have his inflatable penile prosthesis (ipp) removed and replaced on a future date. The future procedure will also be a reconstruction of the corpora cavernosa along with a device replacement.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key9425768
Report Number2183959-2019-67951
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/29/2019
Device MODEL Number72404237
Device Catalogue Number72404237
Device LOT Number0169918006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/06/2019 Patient Sequence Number: 1
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