MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMESH; MESH, SURGICAL, POLYMERIC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Blood Loss (2597); Not Applicable (3189)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure other relevant patient history/concomitant medications product name, product code and/or lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event were there any concomitant procedures performed? when did the bleeding occur? the source and triggering event of bleeding and the volume of blood loss? how the bleeding was treated? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? date of exposed mesh excision? what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown surgical procedure on unknown date and the mesh was implanted.The patient experienced a vaginal mesh exposure and vaginal bleeding and underwent a partial excision of exposed vaginal mesh.Additional information has been requested.

• Brand Name: GYNECARE GYNEMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6885267
• MDR Text Key: 86976904
• Report Number: 2210968-2017-70334
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2017
• 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