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

Catalog Number OPHY2030

Device Problem Delamination (2904)

Patient Problems Hernia (2240); No Code Available (3191)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? was the hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? 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) was there any triggering event prior to present recurrence? (e.G.Weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? are any photographs available? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent incisional hernia repair on (b)(6) 2016 and mesh was implanted.The patient experienced hernia recurrence.The posterior fascia was torn.The mesh was fine except, but had lost its coating.The monocryl layer was not present eight days after being implanted.The patient underwent a second procedure and new mesh was implanted.Additional information has been requested.

• Brand Name: PHYSIOMESH OPEN
• 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: 5900814
• MDR Text Key: 52898359
• Report Number: 2210968-2016-11556
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K141560
• 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: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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: OPHY2030
• Device Lot Number: JM8CBZB0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 78 YR