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

Model Number 810081

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Cyst(s) (1800); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 microwave endometrial ablation and posterior pelvic floor repair on (b)(6) 2010 and mesh was implanted.It was reported that the patient experienced heavy vaginal bleeding and persistent discharge, pelvic pain, dyspareunia, faecal incontinence, soiling, urgency, lower abdominal pain, cysts, cystocele, vaginal abscess and vaginal swelling.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 11/21/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: POSTERIOR PELVIC FLOOR REPAIR
• 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 ; 9083863534
• MDR Report Key: 15697757
• MDR Text Key: 302687454
• Report Number: 2210968-2022-08956
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 810081
• Device Catalogue Number: PFRP01
• Device Lot Number: 3422151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female