MAUDE Adverse Event Report: ETHICON INC. PROSIMA COMBINED SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PROC2

Device Problem Migration (4003)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Prolapse (2475)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and two mesh products were implanted.It was reported that the patient underwent a revision surgery on undisclosed date.It was reported that the patient experienced dyspareunia, urinary problems, erosion, pain and infection.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report #2210968-2017-01187 for previously submitted mdr number 2210968-2017-01655 subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).

Manufacturer Narrative

Date sent to the fda: 3/29/2022.Additional b5 narrative: it was reported that the patient underwent mesh revision on (b)(6) 2014 due to prolapse.

Manufacturer Narrative

Date sent to the fda: 4/5/2022 additional information: d4, h4 a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROSIMA COMBINED SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12840662
• MDR Text Key: 285470792
• Report Number: 2210968-2021-11696
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: PROC2
• Device Lot Number: 3523948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2011
• 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 Sex: Female