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

Catalog Number PFRT01

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Prolapse (2475); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2005 and mesh was implanted.It was reported that the patient concurrently underwent hysterectomy, bilateral salpingo-oophorectomy and cystoscopy.It was reported that she experienced pain, erosion of her internal bodily tissue, extrusion, infection, urinary/bowel problems, recurrence, bleeding, rectovaginal fistula, neuromuscular problems, organ perforation, vaginal scarring, and other injuries following the procedure.It was reported that patient underwent cystoscopy, laparoscopic diverting loop ileostomy in rlq, excision of rectovaginal mesh through a vaginotomy, repair of proctectomy with interrupted sutures and vaginal closure on (b)(6) 2013 due to pop and mesh erosion.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

Manufacturer Narrative

Product complaint # (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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This event was previously submitted under ethicon mdr summary reporting exemption e2013037.Initial psr reporting period: (b)(6), 2014 through (b)(6), 2014.Psr submission number: (b)(4).Psr report identifier: (b)(4).

• 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
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14164618
• MDR Text Key: 289738126
• Report Number: 2210968-2022-02826
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2022

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: 07/31/2006
• Device Catalogue Number: PFRT01
• Device Lot Number: 1338835
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2005
• 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: 54 YR
• Patient Sex: Female