MAUDE Adverse Event Report: ETHICON INC. PROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported in a journal article that the patient underwent a laparoscopic repair of perineal hernia procedure on unknown date and mesh was implanted.During the procedure, the mesh was tacked to the promontory or sacrum and sutured to the pelvic sidewalls and the anterior peritoneum.Twelve months after procedure, the patient experienced recurrence and had a rupture in the center of the mesh.The patient underwent a laparoscopic reoperation.There were no adhesion to the mesh noted during reoperation and another like mesh was sutured to the first mesh.No signs of recurrence were seen six months after reoperation.No further information is available.

• Brand Name: PROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT
• 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.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5708990
• MDR Text Key: 46892188
• Report Number: 2210968-2016-09635
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060713
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 05/19/2016
• 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: 54 YR