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

Model Number	M0068402581
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	03/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that the patient was diagnosed with vaginal prolapse, cystocele, rectocele, and stress urinary incontinence (sui).She was implanted with a polyform device for prolapse repair (with concomitant implant of advantage fit sling) on (b)(6) 2016.As reported by the patient's attorney, the patient underwent a procedure for revision of the polyform mesh on (b)(6) 2017 due to chronic abdominal pelvic pain.Boston scientific has been unable to obtain additional information regarding the event to date.

• Brand Name: POLYFORM SYNTHETIC MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9849264
• Report Number: 3005099803-2020-01209
• Device Sequence Number: 19438456
• Product Code: OTO
• UDI-Device Identifier: 08714729839231
• UDI-Public: 08714729839231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: M0068402581
• Device Catalogue Number: 72843
• Device Lot Number: C002909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR