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

Catalog Number PFRT01

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

Patient Problems Apnea (1720); Arthritis (1723); Foreign Body Reaction (1868); Incontinence (1928); Pain (1994); Anxiety (2328); Depression (2361); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent a gynecological procedure for pelvic prolapse on (b)(6) 2011 and mesh was implanted.Ms monarc sling was implanted to help with bladder and bowel incontinence.Straight after the procedure, the patient reported having pain and the incontinence bladder and bowel was worse than before.All of these symptoms persisted as well as numbness down left leg and pain in both pelvic sides but more so down the right side.Twelve months later, a 2nd ams monarc sling was implanted, hoping it would improve the situation, which it did not.A specimen of mesh was removed when the operation was being done of the prolapse mesh and sent to pathology.It came back showing foreign body reaction from the mesh.The patient further reported major depression, anxiety, scoliosis and sleep apnea.In 2019, a 3d4d ultrasound was done and the 2 slings had turned and were on their side heading towards the urethra.The patient has had numerous sessions of sitting on a neo control chair to try and help, but with no results and the patient also couldn¿t have the machine high as it was giving more pain.Numerous physio consultations to no advantage.Since 2011, the patient has experienced incontinence of bladder and bowel, continuous pelvic pain, numbness down left leg, osteo arthritis, lower back pain, pins and needles in left foot, constipation and mental trauma.No further information is available as reporter details have not been disclosed (confidential).

• 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 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18865872
• MDR Text Key: 337217051
• Report Number: 2210968-2024-02729
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: PFRT01
• Device Lot Number: 3413190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2010
• 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