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U.S. Department of Health and Human Services

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

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COVIDIEN LP LLC NORTH HAVEN UNKNOWN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameUNKNOWN PARIETEX PROGRIP
Type of DeviceMESH, 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 Key12121025
MDR Text Key260023508
Report Number1219930-2021-02671
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PROGRIP
Device Catalogue NumberUNKNOWN PARIETEX PROGRIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/06/2021 Patient Sequence Number: 1
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