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); Calcium Deposits/Calcification (1758); Urinary Tract Infection (2120)

Event Date 09/26/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a hysterectomy on (b)(6) 2010 and the mesh was implanted.It was reported that after undergoing the surgery, recurrent urinary tract infection occurred two years ago.It was reported that a cystoscopy in the hospital last year found that the device eroded the bladder with stone formation.It was also reported that the patient had the bladder stone broken, and some of the device has been removed, but the postoperative curative effect may be poor and easy to relapse.Additional information was requested.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: weight, bmi at the time of index procedure.The diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications? any concurrent procedure/device implantation? were there any intra-operative complications? mesh exposure site/location and symptoms? date - time of onset of infection from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? was medical intervention performed for the infection? results? describe any medical/surgical intervention for the mesh erosion, stone formation and infection including dates and surgical findings.What is the relationship of the infection and the stone formation to the device implanted? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Manufacturer Narrative

(b)(4).Date sent to fda: 06/02/2022.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, 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.Additional information was requested and the following was received: the patient demographic info: weight, bmi at the time of index procedure? unk.The diagnosis and indication for the initial surgical procedure? unk.Other relevant patient history/concomitant medications? unk.Any concurrent procedure/device implantation? unk.Were there any intra-operative complications? unk.Mesh exposure site/location and symptoms? unk.Date - time of onset of infection from the surgical procedure? on september 26, 2021, the infection was found.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? unk.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation?-unk were cultures performed? results? unk.Was medical intervention performed for the infection? unk.Results? unk.Describe any medical/surgical intervention for the mesh erosion, stone formation and infection including dates and surgical findings.Bladder stones were crushed and some patches were removed.What is the relationship of the infection and the stone formation to the device implanted? unk.What is physician¿s opinion as to the etiology of or contributing factors to this event?unk.What is the patient's current status? the patient has now been discharged smoothly.

• 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
• MDR Report Key: 14131682
• MDR Text Key: 293163838
• Report Number: 2210968-2022-02703
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/02/2022

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: 01/31/2013
• Device Catalogue Number: PFRT01
• Device Lot Number: 3405499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/16/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female