MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

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

Patient Problems Bleeding (1738); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Discharge (2225); Discomfort (2330); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure in (b)(6) 2005 and an unknown mesh was implanted.Following the insertion the patient experienced recurrent utis, tightness in the vagina, vaginal bleeding, discharge, groin pain, and dyspareunia for both the patient and the spouse.It was reported that the patient felt the mesh close to the surface.In (b)(6) 2013 the patient¿s pain, bleeding, and utis increased, an area of mesh exposure on the anterior abdominal wall was noted and an area of contracted mesh was felt in the vagina.In (b)(6) 2013 a large amount of mesh was noted crumpled at the side of the anterior vaginal wall, causing inflammation.In (b)(6) 2013 the patient underwent removal of the pelvic mesh.Thereafter the patient suffered persistent pv bleeding and clots.The patient continues to experience discomfort in her vagina, abdomen and pelvis area.

Manufacturer Narrative

(b)46).Conclusion code no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GYNECARE MESH UNKNOWN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4908685
• MDR Text Key: 6542275
• Report Number: 2210968-2015-08167
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• 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