MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Discharge (2225); Urinary Frequency (2275); Surgical procedure (2357); Hematuria (2558); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent gynecological procedures on (b)(6) 2004 and an unknown mesh and non-gynecare product was implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

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

It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent d&c and tubal sterilization due to frequent urination, urinary incontinence, dyspareunia and bladder spasms.It was reported that following insertion the patient experienced urinary problems and bladder spasms.It was reported that patient underwent tubal and thermal ablation on (b)(6) 2005 and underwent mesh removal on (b)(6) 2013 due to erosion, dyspareunia, and vaginal bleeding.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced discharge, urinary frequency and nocturia.

Manufacturer Narrative

It was reported that following insertion the patient experienced genuine stress urinary incontinence and hematuria.

• 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: 4698801
• MDR Text Key: 5723355
• Report Number: 2210968-2015-04562
• Device Sequence Number: 1
• Product Code: OTN
• 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: 08/10/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 04/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2016; 08/30/2016
• 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: 30 YR
• Patient Weight: 118