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

Catalog Number ULTRAPROMUNK

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

Patient Problems Wound Dehiscence (1154); Abdominal Distention (2601); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Surgical intervention, cutaneous dehiscence, omentum externalization occurred.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

It was reported in a journal article that the patient underwent an eventroplasty without closing the anterior sheet procedure on unknown date along with right-sided hemicolectomy and retroperitoneal lipoma removal and the mesh was implanted for abdominal wall reconstruction.The patient operated on to separate the bilateral posterior components.Due to the impossibility of mid-line closure, the edges of the anterior sheet were affixed to the mesh, and a bridge remained.At twenty days following the procedure, the patient experienced cutaneous dehiscence with externalization of the omentum.The patient was examined in surgery, and a central rupture in the mesh was found, which was repaired by closing the defect and using another mesh suturing it above the previous mesh at a subcutaneous position.The abdomen was initially left open and then closed in a second attempt.The patient is without symptoms and has an intact wall.The doctor opined that the distention of the abdominal wall, because intraabdominal surgery had been performed on the subsequent postoperative ileus, and the divergent tractive forces in the areas where the mesh was fixated may have caused the rupture.The doctor also opined that the mesh should be not used in obese patient, when it is unable to close the anterior myofascial layer.No further information is available.

Manufacturer Narrative

(b)(4).Date sent to the fda: 09/06/2019.

• Brand Name: ULTRAPRO 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.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: jane kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 6856368
• MDR Text Key: 85733932
• Report Number: 2210968-2017-70247
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPROMUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2019
• 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: 63 YR