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

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

Patient Problems Unspecified Infection (1930); Other (for use when an appropriate patient code cannot be identified) (2200); Discharge (2225); Hernia (2240); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecological procedure in (b)(6) 2002 and mesh was implanted.Following the procedure, the patient experienced infected sinus in the right suprapubic wound and underwent a partial mesh excision on (b)(6) 2003.It was also reported that the patient experienced a recurrence of wound discharge and further mesh was removed on (b)(6) 2003.The patient experienced a recurrence of wound sinus on the left side and required the removal of sinus and left side mesh on (b)(6) 2005.On (b)(6) 2006, the patient underwent a repair of bladder injury concurrently with removal of remaining mesh due to recurrence of infected sinus.It was reported that the patient developed hernia in incision and required a laparoscopic repair of incisional hernia with mesh removal.Additional information has been requested.

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
• 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 ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4973788
• MDR Text Key: 6084953
• Report Number: 2210968-2015-10884
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974098
• 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: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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: 07/14/2015
• 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