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

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to fda: 11/29/2016.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.

Event Description

It was reported by the patient that she underwent repair of abdominal incisional hernia on (b)(6) 2002 and mesh was implanted.On (b)(6) 2010, the patient had a surgical repair of a chronically incarcerated incisional hernia.The mesh had completely detached from the fascia and several loops of bowel were within the hernia that had densely adhered to the mesh.After lysis of the adhesions, the small bowel was freed and the existing mesh was resected.A new mesh was placed over the hernia defect.The patient reported pain in the left lower quadrant post operatively.No additional information was provided.

• Brand Name: PROLENE HERNIA SYSTEM MESH
• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6132782
• MDR Text Key: 61055111
• Report Number: 2210968-2016-15177
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• 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
• Patient Age: 36 YR