FDA Adverse Event Death Summary report: N

UNKNOWN PROTACK

MDR report key: 8756488 · Received July 3, 2019

Report

Report Number: 2647580-2019-03495
Event Type: Death
Date Received: July 3, 2019
Date of Event: May 20, 2009
Report Date: July 2, 2019
Manufacturer: US SURGICAL PUERTO RICO
Product Code: GDW
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). TITLE: LONG-TERM RESULTS OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS USING AN INTRAPERITONEAL COMPOSITE MESH / ALFREDO MORENO-EGEA Æ JOSE´ ANTONIO CASTILLO BUSTOS Æ ENRIQUE GIRELA Æ JOSE´ LUIS AGUAYO-ALBASINI / SOURCE: 27 JANUARY 2009 / ACCEPTED: 20 MAY 2009 / PUBLISHED ONLINE: 17 JUNE 2009 SPRINGER SCIENCE+BUSINESS MEDIA, LLC 2009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

ACCORDING TO THE LITERATURE, (JANUARY 1994 AND DECEMBER 2006), THIS STUDY AIMED TO EVALUATE THE LONG-TERM COMPLICATIONS AND RECURRENCES OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS. DATA FOR 200 CONSECUTIVE PATIENTS WHO UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR (LIHR) IN A UNIVERSITY TEACHING HOSPITAL ERE COLLECTED PROSPECTIVELY. THE MEDIAN FOLLOW-UP WAS 6 (RANGE, 1¿12) YEARS. A DOUBLE-LAYER MESH WAS USED IN ALL CASES. ONE PATIENT HAD AN INTESTINAL INJURY WHICH DIAGNOSED DURING THE IMMEDIATE POSTOPERATIVE PERIOD AND REOPERATION WAS PERFORMED DUE TO ABDOMINAL SEPSIS. DURING THE OPERATION, AN INTESTINAL RESECTION WAS PERFORMED AND THE PATCH WAS REMOVED. THE PATIENT PROGRESSED TO MULTIPLE ORGAN FAILURE AND DIED AS A RESULT OF A SEPSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
555151	UNKNOWN PROTACK	STAPLE, IMPLANTABLE	GDW	US SURGICAL PUERTO RICO	UNKNOWN PROTACK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death\| O	UNKNOWN PARIETEX