MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PROTACK

Model Number UNKNOWN PROTACK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title experience of laparoscopic incisional hernia repair in kidney and/or pancreas transplant recipients.Source american journal of transplantation.11: 279¿286.Received 29 july 2010, revised 22 october 2010 and accepted for publication 28 october 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed between april 2005 and march 2009, a total of 98 patients underwent laparoscopic incisional hernia repair following either kidney or pancreas.Two patients had features of an acute abdomen postoperatively in the transplant group; one patient underwent laparoscopy on post-operative day two and no pathologic etiology was identified.Another had laparotomy on post-operative day two and a perforation in the small bowel was noted.The perforation repaired and the mesh explanted for fear of infection.One other patient in the transplant group required mesh explant for the infected mesh.This resulted from interventional radiology guided seroma drainage.In the non-transplant group, one patient presented with an acute abdomen on post-operative day seven and was found to have a bowel perforation on laparotomy.The bowel perforation was repaired and the mesh explanted for fear of infection.Another patient had mesh explanted for infected mesh from an uncontrolled wound infection.Five of 31 patients (16%) in the transplant group and 4 of 57 (7%) in non-transplant group had a recurrence of the hernia at a median follow-up of 2.2 and 3 years, respectively.

• Brand Name: UNKNOWN PROTACK
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8801037
• MDR Text Key: 151409742
• Report Number: 2647580-2019-03726
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2019
• 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: 56 YR