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

Catalog Number PROSIMAUNK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2017-01026 for previously submitted mdr number 2210968-2017-01655, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective (b)(6) 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.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.

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and prosima was implanted.It was reported that following insertion the patient experienced nocturia, urinary urgency, urinary tract infection, vaginal bleeding, incontinence, dysuria and pelvic pain.It was reported that the patient underwent a revision surgery on an unknown date.No additional information was provided.

• Brand Name: PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• 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 08869
• MDR Report Key: 12808017
• MDR Text Key: 285353003
• Report Number: 2210968-2021-11332
• 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
• Report Date: 11/12/2021

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 Catalogue Number: PROSIMAUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Sex: Female