MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN PARIETEX PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN PARIETEX PROGRIP

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

Patient Problems Hematoma (1884); Seroma (2069)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Title: quality of life after complex abdominal wall reconstruction source: visc med 2020;36:326¿332 published online: january 14, 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, (2011 to 2016) this study aimed to assess a retrospective study evaluated outcomes of patients who underwent hernia repair using either an open or endoscopically assisted component separation technique.The dissection balloon was used in the endoscopic assisted group.Parietex progrip mesh was used.There were 25 patients in the open group and 10 patients in the endoscopic assisted group.Complications included: seroma, hematoma, necrosis and superficial and sub-fascial complications.Ct guided drainage was required to treat one patient with hematoma/seroma.Reoperations and extended hospital stay were reported.Quality of life after complex abdominal wall reconstruction i mark philipp matthias leuchter ernst klar | received: july 22, 2019 accepted: december 4, 2019 published online: january 14, 2020 | department of general, visceral, vascular, and transplantation surgery, university medical center of rostock, germany.

• Brand Name: UNKNOWN PARIETEX PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12121025
• MDR Text Key: 260023508
• Report Number: 1219930-2021-02671
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PROGRIP
• Device Catalogue Number: UNKNOWN PARIETEX PROGRIP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/06/2021
• 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): Hospitalization; Required Intervention