• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN / MEDTRONIC, INC. MESH SURGICAL PARIETEX L30M X W20 CM VENTRAL HERNIA RECTANGULAR COMPOSITE OPTIMI MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN / MEDTRONIC, INC. MESH SURGICAL PARIETEX L30M X W20 CM VENTRAL HERNIA RECTANGULAR COMPOSITE OPTIMI MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO3020X
Device Problems Degraded (1153); Defective Component (2292)
Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Cramp(s) (2193); Hernia (2240); Sweating (2444)
Event Date 03/06/2014
Event Type  Injury  
Event Description
During my lunch break, i had taken a couple of bites of my sandwich when i experienced a sudden onset of abdominal pain. It caused severe cramping, nausea, sweating and increasing pain. I was able to drive home (less than 5 miles). The pain increased in intensity and 45 mins i knew i needed to get medical attention. I was driven to (b)(6) medical center emergency dept. I was given a ct scan and admitting to the hosp for emergency surgery for hernia repair at old port site between 2 pieces of mesh placed previously on (b)(6) 2012 (parietex l30 cm x w20 cm central hernia rectangular composite sterile polyester textile design strong fix and parietex l6 in x w4 in central hernia composite rectangular sterile polyester mfr, covidien). The mesh shrinking caused the reoccurrence of the hernia. The repair was done and i was discharged on (b)(6) 2014. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH SURGICAL PARIETEX L30M X W20 CM VENTRAL HERNIA RECTANGULAR COMPOSITE OPTIMI
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN / MEDTRONIC, INC.
MDR Report Key9328358
MDR Text Key166788400
Report NumberMW5091095
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model NumberPCO3020X
Device Catalogue NumberLOG388730
Device Lot NumberPMBOO663
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/14/2019 Patient Sequence Number: 1
-
-