MAUDE Adverse Event Report: ETHICON INC. PROLENE*SOFT POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	SPMH
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.If the device or further details are received at the later date a supplemental medwatch will be sent.E2013037.Total number of events ¿ 23.Prolene polypropylene mesh - 12.Prolene soft polypropylene mesh - 2.Ultrapro mesh - 3.Vicryl polyglactin 910 mesh ¿ 6.
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and the mesh was implanted.Following the procedure, the patient experienced pain and erosion of her internal bodily tissue and underwent revisionary procedures.No further information is available.
Additional Manufacturer Narrative
Date sent to fda: 02/22/2018 ethicon mdr summary reporting exemption e2013037 reporting period october 1, 2017 through november 30, 2017 supplemental 01 - attachment: [12-31-2017 ftl supplemental 01.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 04/12/2018 ethicon mdr summary reporting exemption e2013037 reporting period october 1, 2017 through november 30, 2017 supplemental 02 - attachment: [12-31-2017 ftl supplemental 02.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: (b)(4) 2018.Patient codes: (b)(4).It was reported that patient underwent mesh revisions on (b)(4) 2008, (b)(4) 2010, (b)(4) 2015.It was reported that patient underwent mesh revision on (b)(4) 2015.No additional information was provided.Ethicon mdr summary reporting exemption e2013037.Reporting period (b)(4) 2017 through (b)(4) 2017.Supplemental 03 - attachment: [(b)(4) 2017 ftl supplemental (b)(4)].
Additional Manufacturer Narrative
Date sent to fda: 08/17/2018 ethicon mdr summary reporting exemption e2013037 reporting period october 1, 2017 through november 30, 2017 supplemental 04 - attachment: [12-31-2017 ftl supplemental 04.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2017 through (b)(4) 2017.
Additional Manufacturer Narrative
Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.
Additional Manufacturer Narrative
Date sent fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.
Additional Manufacturer Narrative
Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7118498
• Report Number: 2210968-2017-71792
• Device Sequence Number: 1272733
• Product Code: FTL
• UDI-Device Identifier: 10705031050464
• UDI-Public: 10705031050464
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/03/2017

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: 01/31/2013
• Device Catalogue Number: SPMH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017; 10/03/2017; 10/03/2017; 10/03/2017; 10/25/2018; 12/27/2018; 02/11/2019; 04/23/2019
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/22/2018; 04/12/2018; 06/26/2018; 08/17/2018; 10/25/2018; 12/27/2018; 02/11/2019; 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR