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

Catalog Number PFRA01

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Date 01/01/2007

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.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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.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.Related events captured via 2210968-2023-08272 and 2210968-2023-08273.

Event Description

It was reported that a patient underwent a sling procedure on an unknown date and mesh was implanted.The patient reported, since 2007, the mesh is causing vaginal erosion, defecation problems, pain from the waist down, mobility problems, back pain, pain and tightness in the belly, bleeding, expulsion of foul-smelling liquid, since then no sex life, now fistula.Operated on 3 times; hysterectomy and 2 times to cut meshes in vaginal erosion.A month ago, the last intervention, the patient has bleeding, fluid expulsion and is not well.The patient visited the doctors, and they are able to remove the mesh.The diagnosis was atrophic vagina, possible fused bladder fistula in right angle with bleeding, mesh with fused erosion, severe pelvic myofacial syndrome mea, and obturator with symptomatology of nerve compression mmii.The patient has an appointment with the urologist to make me a cystography, study one dynamic.The patient reported being impotent, getting worse every day and not recovered/important disability.Additional information is being requested.

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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Manufacturer Narrative

Date sent to the fda: 12/06/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, 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.

• Brand Name: ANTERIOR PELVIC FLOOR REPAIR S
• 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: 18022049
• MDR Text Key: 326741368
• Report Number: 2210968-2023-08271
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2007
• Device Catalogue Number: PFRA01
• Device Lot Number: 2928174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2006
• 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