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

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Uterine Perforation (2121); Injury (2348); Disability (2371); Weight Changes (2607); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient is unknown. However, it was reported that the patient was over 18 years. Date of event: no event date was reported; however, it was reported that the device was implanted in (b)(6) 2018. Therefore, date of event was approximated to (b)(6) 2018. The complainant was unable to provide the suspect device 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 boston scientific device was implanted into the patient during a procedure performed in (b)(6) 2018 to treat incontinence. As per media post, after the implantation, the patient suffered from pain and there was an absolute tightness as if there was a clamp inside her intestines. The patient had been bleeding for months and had to wear two diapers a day. She was in pain when attempted to have sex. A scan in (b)(6) revealed that the mesh had cut open her uterus and there was a massive cyst inside that did not exist before the operation. Subsequently, the patient had the mesh removed in march last year; however, the pain still continued. The patient claimed that the pain was so bad that she could not leave her bed and go for a run, and for that reason, she gained weight. Boston scientific has been unable to obtain additional information regarding the event to date.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10876058
• MDR Text Key: 217366240
• Report Number: 3005099803-2020-05438
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/27/2020
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/20/2020 Patient Sequence Number: 1