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

Catalog Number PHY1520R

Device Problem Hole In Material (1293)

Patient Problems Adhesion(s) (1695); Pain (1994); 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 that a patient underwent an ipom procedure for an incisional hernia on an unknown date and mesh was implanted.After 4-5 weeks, the patient experienced violent pain which occurred after sex.The patient underwent reoperation and during the procedure it was found that half the mesh had torn and the other half adhered to the colon.The ingrown mesh part also showed adhesions.While disconnecting the mesh from the colon, the bowel was injured.Adhesiolysis with mesh explantation was performed.The explanted mesh was then sent to the pathology to examine for bacterial contamination.Another like device was used to complete the procedure.Additional information has been requested.

• Brand Name: PHYSIOMESH RECTANGULAR
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5344417
• MDR Text Key: 35073690
• Report Number: 2210968-2016-00082
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: PHY1520R
• Device Lot Number: JH8GLCC0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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