MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL MERSILENE POLYESTER FIBER MESH; MESH, SURGICAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2002 and mesh 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

It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with sacral colpopexy, burch urethropexy, bilateral salpingo-oophorectomy and cystoscopy.It was reported that pt underwent mesh excision on (b)(6) 2007 by dr.(b)(6) due to vaginal mesh exposure.

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced infection, recurrence, bleeding, and vaginal scarring.

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced vaginal discharge and prolapse.It was reported that patient underwent multiple removal of mesh on (b)(6) 2007 and (b)(6) 2007 by dr.(b)(6).

• Brand Name: MERSILENE POLYESTER FIBER MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6282442
• MDR Text Key: 65919629
• Report Number: 2210968-2017-60035
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• 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: 04/12/2017
• 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: 59 YR
• Patient Weight: 59