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

Catalog Number 810081

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

Patient Problems Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Treatment with medication(s) (2571)

Event Date 07/02/2009

Event Type  Injury  

Event Description

It was reported that the patient underwent hysterectomy on (b)(6) 2009 and mesh was implanted.The patient was discharged on (b)(6) 2009 and no abnormal pain was reported.On (b)(6) 2009, the patient was re-examined and complained of pain on both right lower and lower limb.On (b)(6) 2010, the patient went to the hospital and described paroxysmal pain on the left thigh which had affected daily activities.The patient refused to take physical exam and requested that the surgeon remove the mesh.After consultation, physiotherapy or closed treatment was suggested.The patient declined and was discharged.On (b)(6) 2010, the patient was re-hospitalized and accepted further treatment.The patient was treated with ibuprofen, oxycodone, efexor xr, zyprexa, estazolam, premarin and tibolone tablets and endotoxin injection.The patient has experienced slow urination and leakage of urine when listening to the sound of water leakage when washing face and brushing teeth.The physician opines that pain may be caused by the mesh, which stimulates the nerve inflammation around the scar or slight periostitis.It was reported that the physician does not suggest removing the mesh since it has been implanted for more than 1 year.It was reported that the patient has been in this hospital more than 4 years and patient reports condition is worse.

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 TVT OBTURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• 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 ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4925138
• MDR Text Key: 6052721
• Report Number: 2210968-2015-08714
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 62