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

Model Number	1008305
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a boston scientific employee representative identified a label description issue.An ams 700 lgx ms 12cm inflatable penile prosthesis (ipp) with an infrapubic indication was mislabeled with a penoscrotal indication.

• 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 Key: 8257658
• Report Number: 2183959-2019-60186
• Device Sequence Number: 16670678
• Product Code: FHW
• UDI-Device Identifier: 00878953005751
• UDI-Public: 00878953005751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: Lay User/Patient
• Device Expiration Date: 04/13/2022
• Device Model Number: 1008305
• Device Catalogue Number: 1008305
• Device Lot Number: 168857008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1