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

Catalog Number PFRT01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This emdr represents supplemental report # psr-44675 for previously submitted mdr number 2210968-2018-75203, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037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).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

Event description: it was reported that the patient underwent a gynecological surgery on (b)(6) 2008 and prolift was implanted.No additional information was provided.

• Brand Name: TOTAL PELVIC FLOOR REPAIR SYST
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12669672
• MDR Text Key: 281402158
• Report Number: 2210968-2021-09582
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/20/2021

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 Expiration Date: 07/31/2010
• Device Catalogue Number: PFRT01
• Device Lot Number: 3067028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR