MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

Catalog Number PFRT01

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2008 and an unk mesh product was implanted.It was reported that she 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).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

Date sent to the fda: 4/13/2016.

Manufacturer Narrative

(b)(4).It was reported that the patient concurrently underwent hemorrhoidectomy.It was reported that following insertion the patient experienced extrusion, infection, urinary problems and bleeding.It was reported that the patient underwent mesh revision/removal on (b)(6) 2011; (b)(6) 2007 by dr.(b)(6) due to pain (per plaintiff information).

• 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4782029
• MDR Text Key: 5798179
• Report Number: 2210968-2015-06054
• 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: 04/16/2016

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
• Device Expiration Date: 03/31/2010
• Device Catalogue Number: PFRT01
• Device Lot Number: 3027761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2016; 04/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2007
• 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: 46 YR
• Patient Weight: 73