MAUDE Adverse Event Report: COVIDIEN COVIDIEN PARIETEX PROGRIP HERNIA MESH

Lot Number SK700377

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994); Anxiety (2328); Disability (2371); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 07/13/2011

Event Type  Injury  

Event Description

Pt called to report adverse reactions to covidien paritex progrip, which he had implanted on (b)(6) 2011, due to an inguinal hernia. Pt stated since implantation of the parietex progrip mesh, he experiences constant pain in his right testicle. He also stated he has severe pain starting in his right groin up to his belly button. He also experiences pain down the inside of his leg to the bottom of his foot. Pt also says he often feels an "electrical jolt" feeling between his testicle and leg, on the back of his knee, and where the pain ends up through his groin. He stated his lower abdominal area is also in constant pain and has spasms. Pt says he received no warning from his doctor or surgeon of possible adverse reactions or side effects, he was only told there is a 2% chance of reoccurrence. His everyday living has been severely impaired and he says he is basically disabled due to constant pain. Pt is concerned the mesh is possibly poisoning him since it's made of polyester. He said he used to do auto body work and painted cars for 13 yrs, and was very used to things with "poly" in them. Now, he claims the smell of anything with "poly" in it makes him sick. He stated he takes pain medication, but it doesn't really help. He says his sleep is disrupted, he sleeps very little due to pain, and the little amount of sleep causes some anxiety for him. He said he had the mesh implanted at (b)(6).

• Brand Name: COVIDIEN PARIETEX PROGRIP
• Type of Device: HERNIA MESH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 2943724
• MDR Text Key: 3227504
• Report Number: MW5028819
• Device Sequence Number: 1
• Product Code: FTL
• 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: 02/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: SK700377
• Is the Reporter a Health Professional?: No

Patient Treatment Data

Date Received: 02/04/2013 Patient Sequence Number: 1