MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL; MESH, SURGICAL, POLYMERIC

Catalog Number PHY1520V

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to fda: 06/27/2016.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure what were current symptoms following the index surgical procedure? onset date? date of initial surgical procedure? date that the surgeon first noted the mesh was not incorporated? other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event? was the hernia repair associated with this event performed on primary or recurrent hernia? mesh size and overlap? in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra-abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) how was the event diagnosed? what is the patient¿s current status? has medical or surgical intervention been provided or scheduled? please provide dates and results.Photos show areas of mesh that are not incorporated.However, the reason for insufficient incorporation cannot be determined.

Event Description

It was reported that the patient underwent a laparoscopic inguinal hernia repair procedure on (b)(6) 2016 and mesh was implanted.Following the procedure, it was found that the mesh never integrated to the tissues.Additional information has been requested.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PHYSIOMESH OVAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5750573
• MDR Text Key: 48201627
• Report Number: 2210968-2016-09974
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K093932
• 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,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PHY1520V
• Device Lot Number: JM8DLXD0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2015
• 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