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

Catalog Number PROC2

Device Problem Material Erosion (1214)

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

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted.It was reported that the patient 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).

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).Reporting period april 1, 2015 through may 31, 2015.

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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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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2015.

Manufacturer Narrative

Date sent to the fda: 04/19/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

(b)(4).

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Ethicon mdr summary reporting exemption e2013037.Reporting period (b)(4) 2015 through (b)(4) 2015.Supplemental 12 - attachment: [06-30-2015 otp supplemental 12.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 14 - attachment: [(b)(6) 2015 otp supplemental 14.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 15 - attachment: [(b)(6) 2015 otp supplemental 15.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Date sent to fda: 08/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Date sent to fda: 12/28/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2015 through may 31, 2015.

Manufacturer Narrative

Date sent to fda: 06/23/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2015 through may 31, 2015.

• Brand Name: GYNECARE PROSIMA 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
• MDR Report Key: 4862311
• MDR Text Key: 5850157
• Report Number: 2210968-2015-02673
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/03/2015

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: 09/30/2012
• Device Catalogue Number: PROC2
• Device Lot Number: 3416582
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 06/23/2015
• 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; 03/02/2015; 03/02/2015; 03/02/2015; 03/02/2015; 03/02/2015; 03/02/2015; 03/02/2015; 10/26/2018; 12/28/2018; 02/12/2019; 04/24/2019; 08/23/2019; 06/23/2020
• Supplement Dates FDA Received: 10/27/2015; 12/21/2015; 02/23/2016; 04/22/2016; 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; 12/22/2017; 02/26/2018; 04/17/2018; 06/21/2018; 08/16/2018; 10/28/2018; 12/28/2018; 02/12/2019; 04/24/2019; 08/23/2019; 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR