MAUDE Adverse Event Report: ETHICON INC. GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Catalog Number TC043

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Surgical procedure (2357); Obstruction/Occlusion (2422); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent a hysteroscopy, d&c and an endometrial thermal ablation for pelvic pain, menorrhagia and dysmenorrheal in (b)(6) 2013.The patient complained of considerable post operative discomfort requiring extra analgesia.The patient was re-admitted to the hospital on (b)(6) 2013 and was suffering from persistent lower abdominal pain since the procedure, fevers and rigors.The patient underwent an emergency laparotomy on (b)(6) 2013 for a suspected pelvic abscess seen in the pouch of douglas visualized on ultrasound.The patient had evidence of pyrexia, foul-smelling discharge and vomiting with lower abdominal pain.Her inflammatory markers were raised.Intraoperatively, sterile pus was seen in the pouch of douglas.There was no evidence of uterine perforation, thermal injury, rectosigmoid perforation or fistula.The patient failed to improve.On (b)(6) 2013, a ct scan confirmed a sub-acute bowel obstruction and the patient required the insertion of an ng tube and parental nutrition.On (b)(6) 2013, the patient underwent a laparotomy, division of adhesions and laparoscopic repair of an incisional hernia with mesh.Marked adhesions were noted in the anterior abdominal wall.A hernia containing small bowel adhesions was divided and the bowel was released.The loop of small bowel was stuck in the mesh repair.The patient was discharged home on (b)(6) 2013.She was then readmitted to the hospital with a wound infection on (b)(6) 2013.Following surgery, the patient has suffered from pain in left iliac fossa with a degree of hyperaesthesia and tenderness in the lower abdomen.In (b)(6) 2013, the patient underwent a ct scan which did not show any evidence of recurrent hernia or any collections or abscesses within the abdomen to account for her pain.The patient continues to experience pain and difficulty with sexual relations.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3576502
• MDR Text Key: 4080085
• Report Number: 2210968-2014-00334
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TC043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2013
• 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): Hospitalization; Required Intervention