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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 UNK-P-IPP
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
Device not returned for evaluation.
 
Event Description
It was reported that due to urethral erosion and infection the patient had his inflatable penile prosthesis (ipp) removed and replaced with a 11mmx16cm-25cm tactra concealable prosthesis.It was added that the physician is unsure about the cause of the erosion and the patient complained of a lot of pain.It was further reported that the patient is doing well after this surgery and the explanted device will not be returned for evaluation.It was further reported that this patient experienced erosion, causing the infection.
 
Manufacturer Narrative
Correction: updated to include device coding.Device not returned for evaluation.
 
Event Description
It was reported that due to urethral erosion and infection the patient had his inflatable penile prosthesis (ipp) removed and replaced with a 11mmx16cm-25cm tactra concealable prosthesis.It was added that the physician is unsure about the cause of the erosion and the patient complained of a lot of pain.It was further reported that the patient is doing well after this surgery and the explanted device will not be returned for evaluation.It was further reported that this patient experienced erosion, causing the infection.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9372843
MDR Text Key167973175
Report Number2183959-2019-67637
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/26/2019
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
Device Operator Lay User/Patient
Device Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/05/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received11/26/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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