MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Depression (2361)

Event Date 05/23/2008

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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, 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.(b)(4).If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent a trans vaginal tape procedure on (b)(6) 2008 and the mesh was implanted.It was reported that the procedure was due to stress incontinence and urgency.It was reported that the procedure did not work.It was reported that the symptoms that make the patient's incontinence worse are a full meal, standing too long, sexual intercourse, full bowel, walking, coughing, sneezing, lifting, bowel movements, exercise, full bladder and stress.It was reported that the patient had menorrhagia and had a mirena put in, and also has vaginal discharge.It was also reported that the procedure has also made sexual intercourse very painful, consequently the patient no longer has intercourse.It was reported that the patient experiences a lot of lower abdominal sharp pains and lower back pain which the patient had physio, chiro and steroid injections with no help.It was also reported that the incontinence and pain have all impacted on the patient's mood and the patient has suffered from depression for some time now.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15152848
• MDR Text Key: 297126282
• Report Number: 2210968-2022-06208
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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