MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; MESH, SURGICAL, POLYMERIC

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

Patient Problems Urinary Retention (2119); Injury (2348)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

The event date was approximated to (b)(6) 2019, the date the complaint was first reported to bsc, as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a bsc mesh was implanted during a procedure performed.According to the complainant, everyday, the patient pays a high price to perform bodily functions.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a bsc mesh was implanted during a procedure performed.According to the complainant, after the procedure, everyday, the patient pays a high price to perform bodily functions.Furthermore, the patient has also experienced "faulty" bladder which ruined her ability to urinate normally.Reportedly, the patient did not have a surgical treatment only because as per her physician, she was no longer a surgical candidate.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3: the event date was approximated to (b)(6) 2019, the date the complaint was first reported to bsc, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Blocks h6: patient code of 2348 captures the reportable event of the patient paying a high price to perform bodily functions.Patient code of 2119 captures the reportable event of inability to urinate normally.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9309231
• MDR Text Key: 166931394
• Report Number: 3005099803-2019-05420
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other