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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS; PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS; PROSTHESIS PENILE Back to Search Results
Model Number 72400453
Device Problems Break (1069); Defective Device (2588); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2019
Event Type  Injury  
Event Description
It was reported that the patient experienced disconnection of the cylinder with a malleable penile prosthesis (mpp).The mpp was explanted and a new inflatable penile prosthesis (ipp).Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
 
Manufacturer Narrative
Device analysis: malfunction was reported.The two 600m malleable cylinders were visually inspected.Both cylinders had a fractured wire bundle.Both cylinders were not functionally tested due to the fractured wire bundles.Based on the results of this investigation, no escalation is necessary.
 
Event Description
It was reported that the patient experienced disconnection of the cylinder with a malleable penile prosthesis (mpp).The mpp was explanted and a new inflatable penile prosthesis (ipp).Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that the cylinders were broken in 2 pieces, and the patient could not bend the mpp.
 
Event Description
It was reported that the patient experienced disconnection of the cylinder with a malleable penile prosthesis (mpp).The mpp was explanted and a new inflatable penile prosthesis (ipp).Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that the cylinders were broken in 2 pieces, and the patient could not bend the mpp.
 
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Brand Name
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
Type of Device
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8731688
MDR Text Key149102299
Report Number2183959-2019-64564
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
PMA/PMN Number
K912935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/12/2013
Device Model Number72400453
Device Catalogue Number72400453
Device Lot Number572858006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Date Manufacturer Received08/07/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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