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

Catalog Number PFRT01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Micturition Urgency (1871); Itching Sensation (1943); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Prolapse (2475); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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

It was reported by an attorney that the patient underwent a gynecological procedure in 2007 and mesh was implanted.It was reported that the patient underwent removal surgery in 2019.It was reported that the patient experienced pain.No additional information was provided.

Manufacturer Narrative

Date sent to fda: (b)(6) 2020.Additional information: d1, d4, d6, d7, h4.Additional b5 narrative: it was reported the patient underwent a hysterectomy on (b)(6) 2007, and prolift and gynecare tvt was implanted.The patient underwent removal surgery on (b)(6) 2019.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 03/25/2021.Additional b5 narrative: it was reported that the patient experienced vaginal scarring, vaginal prolapse, foreign body and exposed mesh following surgery.

Manufacturer Narrative

Date sent to the fda: 1/30/2023.Additional b5 narrative: it was reported that the patient experienced urine leakage with intercourse, urinary urgency, vaginal itching, and incomplete bladder emptying.

• Brand Name: TOTAL PELVIC FLOOR REPAIR SYST
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10747749
• MDR Text Key: 213430325
• Report Number: 2210968-2020-08382
• 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,Followup,Followup,Followup
• Report Date: 10/27/2020

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: 08/31/2010
• Device Catalogue Number: PFRT01
• Device Lot Number: 3074115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 03/22/2021; 01/26/2023
• Supplement Dates FDA Received: 10/30/2020; 03/25/2021; 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2007
• 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