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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION MESH, SURGICAL, POLYMERIC Back to Search Results
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.

 
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Type of DeviceMESH, 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 Key10876058
MDR Text Key217366240
Report Number3005099803-2020-05438
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
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 Received11/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
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
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