MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problems Material Erosion (1214); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Bleeding (1738); Erosion (1750); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by the patient that she underwent a robotic hysterectomy to treat heavy periods and stress urinary incontinence in 2012 and a sling was implanted.In the recovery room, she experienced an extreme burning sensation in the groin and could not urinate properly.She was released the same day as the procedure.The next month, she experienced bleeding, pubic pain and urination which was not normal and returned to her surgeon who released her to back to work.Over the next few months, the groin pain became more severe, bleeding heavier, urination interrupted, constant urinary tract infections, hemorrhage after having sex and sitting at work became more difficult.In 2013, she returned to the surgeon with severe pain, unsteady gait, bleeding and another urinary tract infection and was referred to pain management.Later in 2013, she experienced extreme pain and uncontrolled blood sugars from the repeated urinary tract infections and type 1 diabetes.In the emergency room tests were performed and it was found that due to the sling the bladder was not working correctly.A leg bag catheter was placed, antibiotics given and she was referred to a urologist who found the bladder was not emptying because of the sling.The patient has undergone two revision surgeries including a repair for a thin vaginal wall from a possible erosion.The patient¿s ability to walk is severely compromised, she has undergone physical therapy and medication treatment and has been told she is permanently disabled.She states she has lost her normal life, ease of blood sugar, ability to provide through working and can't walk well or sit and must lay to get relief from pain.Additional information is not available.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.This medwatch report is in response to receipt of maude event report (b)(4).

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4870750
• MDR Text Key: 6048523
• Report Number: 2210968-2015-07577
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• 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