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

Catalog Number PFRT01

Device Problem Material Erosion (1214)

Patient Problems Bleeding (1738); Erosion (1750); Pain (1994); Scar Tissue (2060); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2005 and 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).Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(4).Total number of events - 306.Gynecare prolift +m anterior pelvic floor repair system - 13.Gynecare prolift +m pelvic floor repair system - 7.Gynecare prolift +m posterior pelvic floor repair system - 20.Gynecare prolift +m total pelvic floor repair system - 22.Gynecare prolift anterior pelvic floor repair system - 69.Gynecare prolift pelvic floor repair system - 47.Gynecare prolift posterior pelvic floor repair system - 35.Gynecare prolift total pelvic floor repair system - 63.Gynecare prosima pelvic floor repair system - 30.

Manufacturer Narrative

(b)(4).

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(b)(4).

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(b)(4).

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(b)(4).

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During the initial procedure, the patient underwent an anterior and posterior repair, vaginal vault suspension.Following the insertion, the patient experienced pain, erosion, urinary problems, bleeding and vaginal scarring.(b)(4).

Manufacturer Narrative

(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).

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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)(6) 2014.Supplemental report 14.

Manufacturer Narrative

(b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Date sent to the fda: 02/22/2017.(b)(4).Reporting period april 1, 2014 through may 31, 2014.Supplemental report 16.

Manufacturer Narrative

Date sent to the fda: 04/19/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014.Supplemental report 18.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2014 through (b)(6) 2014 supplemental report 23 - attachment: [(b)(6) 2014 otp supplemental 23.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Date sent to fda: 12/26/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2014 through may 31, 2014.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2014 through may 31, 2014.

• Brand Name: GYNECARE PROLIFT TOTAL 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: 3897964
• MDR Text Key: 4544623
• Report Number: 2210968-2014-03873
• 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: 03/26/2014

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: 03/31/2006
• Device Catalogue Number: PFRT01
• Device Lot Number: 1298938
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 06/26/2014
• 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; Not provided; Not provided; Not provided; 03/24/2014; 03/24/2014; 03/24/2014; 03/24/2014; 03/24/2014; 03/24/2014; 03/24/2014; 10/26/2018; 12/26/2018; 02/12/2019; 04/24/2019
• Supplement Dates FDA Received: 08/29/2014; 10/29/2014; 12/30/2014; 02/23/2015; 04/28/2015; 06/22/2015; 10/26/2015; 12/21/2015; 02/23/2016; 04/20/2016; 06/20/2016; 08/22/2016; 10/25/2016; 12/19/2016; 02/22/2017; 04/19/2017; 06/26/2017; 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: 04/07/2005
• 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: 60 YR