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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE Back to Search Results
Model Number 72404321
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/05/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that there was foreign body material found inside the blister package.The material was opened during doctor's revision surgery.One of the 1 cm extenders present in the blister was irrigated with antibiotic and implanted in the patient.The physician did not know what the foreign material was as when the package was opened the foreign material was there.The foreign material was identified when the package was opened.
 
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Brand Name
RTE SNAPCONE
Common Device Name
PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9528585
Report Number2183959-2019-68316
Device Sequence Number3175697
Product Code FHW
UDI-Device Identifier00878953004051
UDI-Public00878953004051
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) 12/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/06/2021
Device Model Number72404321
Device Catalogue Number72404321
Device Lot Number0140628055
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/05/2019
Initial Report FDA Received Date12/29/2019
Patient Sequence Number1
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