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 Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Discomfort (2330); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Date 10/07/2013

Event Type  Injury  

Event Description

It was reported that the patient underwent a bilateral hernia repair procedure on (b)(6)2013 and mesh was implanted concurrently with atrium prolite and atrium preshape meshes.Following the procedure, the patient experienced chronic severe pain over the abdominal area, discomfort, 20 pound weight loss, fatigue, rectum problem and difficulty in walking, standing, lifting, bending and reaching.The patient became lactose intolerant and also was unable to tolerate food such as eggs, peanut butter and food that cause gas.In 2014 the patient had no relief from prescribed flector patches and combined cream containing eight medications to rub on the affected area.In 2014 the patient experienced black bumps formed around the rectum, which had to be removed and sent to the lab.The results were inconclusive and the patient was told to get a biopsy.The doctor suggested a long needle shot in the mesh area more than once to numb the area.The patient decided to not get the procedure performed.In 2014, the physician scoped the patient and opines that possibly the rectum problem may be caused from the mesh.The patient was prescribed to 6-week sitz bath of witch hazel and aloe vera, combined anti-inflammatory cream and numbing agent and underwent examination twice then with no relief.In between, the patient experienced shingles and bronchitis due to her weakened condition.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 07/14/2015 (b)(4).Conclusion code: 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 mw5041456.

• 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: 4912785
• MDR Text Key: 21055121
• Report Number: 2210968-2015-08410
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA 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
• Treatment: ATRIUM PROLITE, ATRIUM PRESHAPE
• Patient Outcome(s): Required Intervention