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	Erosion (1750); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); No Code Available (3191)
Date of Event	11/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2016 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The devices were implanted at (b)(6) by dr.(b)(6).(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
Note: this manufacturer report pertains to the second of two devices implanted during the same procedure.It was reported to boston scientific corporation that an advantage fit and a polyform mesh were implanted on (b)(6) 2016.As reported by the patient's attorney, the patient experienced the following injuries: pain, nerve entrapment, erosion, infection and mesh removal.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: 9533730
• Report Number: 3005099803-2019-06121
• Device Sequence Number: 2217315
• Product Code: OTO
• UDI-Device Identifier: 08714729839231
• UDI-Public: 08714729839231
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 12/30/2019

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: 12/05/2019
• Initial Report FDA Received Date: 12/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention