MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT RETROPUBIC DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041BL

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

Patient Problems Cyst(s) (1800); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994)

Event Date 11/21/2023

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.

Event Description

It was reported that a patient underwent an ambulatory operation for insertion of urinary clips and strips on (b)(6) 2023 and mesh was implanted.The patient reported that on the day of the operation, the doctor said there was a complication.The doctor touched the pelvic bone by putting on the strips.After the operation, the patient was injected with 14mg of morphine so much the pain was intense.One month later, the gynecologist said the patient had a hemorrhagic cyst of 6cm.The patient informed the doctor that they are still experiencing great pains and the right side completely anesthetized and that they can no longer hold back because they no longer have any brakes for urinary urges.Pelvic ultrasound on (b)(6) 2024 found a hemorrhagic cyst of 58x39x52mm on the left ovary.The doctor received the patient the same day of the ultrasound and said this cyst is due to the operation and to be patient.The cyst presses on the bladder permanently.The patient further reported urinary loss and anesthetized right side of the lower belly and the right upper thigh.No further information is available as the reporter contact details were not disclosed.

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• 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: 18769338
• MDR Text Key: 336186141
• Report Number: 2210968-2024-01816
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012628
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810041BL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/23/2024
• 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