MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL VICRYL POLYGLACTIN 910 MESH; MESH, SURGICAL, POLYMERIC

Catalog Number VWML

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem 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) 2000 and mesh was implanted.It was reported that she experienced undisclosed injuries.No additional information was provided.

Manufacturer Narrative

In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.

• Brand Name: VICRYL POLYGLACTIN 910 MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem NJ 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt NJ D-228 51; GM D-22851
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6174944
• MDR Text Key: 62419197
• Report Number: 2210968-2016-15491
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810428
• 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: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2005
• Device Catalogue Number: VWML
• Device Lot Number: PC2529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2000
• 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: 75 YR