MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 720056-02

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Scarring (2061); Fluid Discharge (2686)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.

Event Description

It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason.A new spp was implanted in the right side only.No information about the patient's outcome was provided.Additional information received.The patient presented a small hole with drainage on the lateral aspect of his penis.There was no cylinder in the left side due to scarring in left corporal body.No device malfunction with previous spp.

Event Description

It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason.A new spp was implanted in the right side only.No information about the patient's outcome was provided.Additional information received.The patient presented a small hole with drainage on the lateral aspect of his penis.There was no cylinder in the left side due to scarring in left corporal body.No device malfunction with previous spp.

Manufacturer Narrative

H6: patient codes corrected.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.

Manufacturer Narrative

H6: patient codes corrected.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.

Event Description

It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason.A new spp was implanted in the right side only.No information about the patient's outcome was provided.Additional information received.The patient presented a small hole with drainage on the lateral aspect of his penis.There was no cylinder in the left side due to scarring in left corporal body.No device malfunction with previous spp.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9897112
• MDR Text Key: 186676409
• Report Number: 2183959-2020-01678
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005249
• UDI-Public: 00878953005249
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: 720056-02
• Device Catalogue Number: 720056-02
• Device Lot Number: 0183201005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/09/2020; 04/13/2020
• Supplement Dates FDA Received: 04/01/2020; 04/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR