MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient with an unspecified penile prosthesis implant contacted boston scientific patient education team, asking if the implant causes the glans to swell up and reporting trouble achieving orgasm.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom is a known risk associated with inflatable penile prosthesis (ipp) procedures and is noted as such in the ipp instructions for use (ifu).Device history record (dhr): a dhr and ship history review cannot be performed as the lot numbers were not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the ipp ifu was reviewed.The patient symptoms of swelling were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient with an unspecified penile prosthesis implant contacted boston scientific patient education team, asking if the implant causes the glans to swell up and also reporting trouble achieving orgasm.

• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12891595
• MDR Text Key: 281959881
• Report Number: 2124215-2021-36742
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other