MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2004 and mesh was implanted.Following surgery, the patient's stress incontinence returned and she had symptoms of an overactive bladder.It was reported that the patient suffers ongoing pain and inconvenience.She has undergone a number of procedures, can feel the tape and feels pain on sexual intercourse.No additional information was provided.

• Brand Name: GYNECARE MESH UNKNOWN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6018054
• MDR Text Key: 57051658
• Report Number: 2210968-2016-60028
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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: 09/19/2016
• 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
• Patient Age: 52 YR