MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted due to sui.It was reported that following insertion the patient experienced pain, erosion of her internal bodily tissue, infection, urinary problems, recurrence and neuromuscular problems.It was reported that the patient has undergone multiple surgeries and revisionary procedures, including an excision of mesh on (b)(6) 2012 due to erosion and risk of organ perforation.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2011 and a mesh was implanted.It was reported that the patient underwent interstim lead and lmpluse generator placement with intraoperative fluoroscopy on (b)(6) 2012, due to urgency and frequency.No additional information was provided.

Manufacturer Narrative

It was reported that the patient concurrently underwent cystoscopy, bladder biopsies and retrograde pyelogram ((b)(6) 2009), transvaginal tape/gynecare with cystoscopy ((b)(6) 20011).

Manufacturer Narrative

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4023018
• MDR Text Key: 4841970
• Report Number: 2210968-2014-11817
• Device Sequence Number: 1
• Product Code: PAH
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 75 YR
• Patient Weight: 88