MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRP01

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4).Total number of events - (b)(4).Gynecare prolift +m anterior pelvic floor repair system - (b)(4).Gynecare prolift +m pelvic floor repair system - (b)(4).Gynecare prolift +m posterior pelvic floor repair system - (b)(4).Gynecare prolift +m total pelvic floor repair system - (b)(4).Gynecare prolift anterior pelvic floor repair system - (b)(4).Gynecare prolift pelvic floor repair system - (b)(4).Gynecare prolift posterior pelvic floor repair system - (b)(4).Gynecare prolift total pelvic floor repair system - (b)(4).Gynecare prosima pelvic floor repair system - (b)(4).

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(b)(4).

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(b)(4).

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(b)(4).

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(b)(4).Reporting period (b)(4).2014.

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(b)(4).Reporting period october 1 2014 through november 30, 2014.

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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014.

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(b)(4).Reporting period (b)(4) 2014.

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(b)(4).Reporting period (b)(6) 2014.

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(b)(4).Reporting period (b)(4) (b)(4) 2014.

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Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2014 through (b)(6) 2014 supplemental report 16 - attachment: [(b)(6) 2014 otp supplemental 16.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).

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Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014 through (b)(4) 2014.

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Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

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Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

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Date sent to fda: 12/26/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1 2014 through november 30, 2014.

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Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2014 through november 30, 2014.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2014 through november 30, 2014.

• Brand Name: GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4371171
• MDR Text Key: 5291714
• Report Number: 2210968-2014-12599
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/04/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: PFRP01
• Device Lot Number: 3238537
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 10/26/2018; 12/26/2018; 02/12/2019; 04/24/2019
• Supplement Dates FDA Received: 02/24/2015; 04/29/2015; 06/22/2015; 10/27/2015; 12/21/2015; 02/23/2016; 04/21/2016; 06/21/2016; 08/23/2016; 10/26/2016; 12/19/2016; 02/23/2017; 04/19/2017; 06/27/2017; 08/28/2017; 10/23/2017; 12/20/2017; 02/27/2018; 04/18/2018; 06/21/2018; 08/16/2018; 10/28/2018; 12/26/2018; 02/12/2019; 04/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR