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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404280
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Reservoir, model- 720182-01, lot sn- (b)(4), mfg date- 03/01/2018, exp date- 03/01/2018, gtin- (b)(4).Device not returned for evaluation.
 
Event or Problem Description
It was reported that due to difficulty with pumping the patient will have his inflatable penile prosthesis (ipp) removed and replaced.It was explained that during evaluation the physician noted the pump does not refill after pumping.Should additional information be received a supplemental report will be submitted.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8861063
Report Number2183959-2019-65491
Device Sequence Number19289799
Product Code FHW
UDI-Device Identifier00878953003832
UDI-Public00878953003832
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date12/10/2021
Device Model Number72404280
Device Catalogue Number72404280
Device Lot Number0156868002
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2019
Initial Report FDA Received Date08/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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