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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Hernia (2240); Numbness (2415); No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This medwatch report is in response to receipt of maude event report mw5062576.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.(b)(4).

Event Description

It was reported that the patient underwent a panniculectomy procedure with abdominal reconstruction/abdominoplasty on (b)(6) 2008 and the mesh was implanted due to mid lower abdominal muscular diastasis with prolapse of the abdominal contents and a secondary panniculus with an inferior roll.Ever since the surgery, the patient experienced a pain and developed a hernia.Two to three years following the procedure, the patient was still experiencing an abdominal pain and numbness.It was also reported by the patient that according to a doctor, the patient's hernia was a result of the mesh.No new surgery has been performed yet to correct a patient's condition.Currently, the patient is still experiencing abdominal pain, profuse sweating and numbness over abdominal area and legs.

• Brand Name: ULTRAPRO 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): 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: 5844247
• MDR Text Key: 51109693
• Report Number: 2210968-2016-11077
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/03/2016
• 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: 47 YR
• Patient Weight: 97