MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); 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 info 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 to treat sui on (b)(6) 2013 and an mesh was implanted into the patient.It is reported that the patient experienced pain, infection, urinary problems, dyspareunia, neuropathic problems, incontinence, erosion of her internal bodily tissue and other injuries, and she has undergone additional surgeries and revisionary procedures.No additional information is provided at this time.

Manufacturer Narrative

It was reported that the patient underwent gynecological surgical procedure and a mesh was implanted concurrently with hysterectomy.It was reported that following insertion the patient experienced bleeding.

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced recurrence and dyspareunia.

• Brand Name: GYNECARE MESH UNKNOWN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-PENDING DETERMINATION; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6092018
• MDR Text Key: 59554980
• Report Number: 2210968-2016-14849
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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
• Report Date: 05/16/2017

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: 11/08/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2017; 05/17/2017
• 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: 40 YR