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

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).

• Brand Name: MESH SURGICAL PARIETEX L30M X W20 CM VENTRAL HERNIA RECTANGULAR COMPOSITE OPTIMI
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN / MEDTRONIC, INC.
• MDR Report Key: 9328358
• MDR Text Key: 166788400
• Report Number: MW5091095
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2014
• Device Model Number: PCO3020X
• Device Catalogue Number: LOG388730
• Device Lot Number: PMBOO663
• 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