MAUDE Adverse Event Report: ETHICON INC. PROLENE* HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number PHSM

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Adhesion(s) (1695); Vomiting (2144); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.This medwatch report is in response to receipt of maude event report number: mw5062880.

Event Description

It was reported that the patient underwent a hernia repair procedure on (b)(6) 2013 and mesh was implanted.In 2016, the patient reported that they became very sick and was throwing up for 10 days and had diarrhea.The patient went to the emergency room three times and it was found that the patient had a bowel obstruction.The mesh had come loose and attached to the intestine.The patient underwent reoperation on (b)(6) 2016 and a situation of the intestine was removed.The patient reported that she is currently feeling better, but still experience minor stomach issues.No additional information was provided.

• 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): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5837903
• MDR Text Key: 50899910
• Report Number: 2210968-2016-10960
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHSM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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