FDA Adverse Event Injury Summary report: N

BARD PERFIX PLUG EXTRA LARGE, MONOFILAMENT KNITTED POLYPROPYLENE

MDR report key: 2100928 · Received May 18, 2011

Report

Report Number
MW5020679
Event Type
Injury
Date Received
May 18, 2011
Date of Event
May 14, 2009
Report Date
May 18, 2011
Manufacturer
DAVOL INC.
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

ON (B)(6) 2008 OUR CLIENT SUFFERED A BILATERAL INGUINAL HERNIA, WHICH REQUIRED SURGERY. OUR CLIENT HAD SURGERY TO REPAIR THE HERNIA ON (B)(6) 2008. CR BARD EXTRA LARGE MESH PERFIX PLUGS WERE USED TO REPAIR THE LEFT AND RIGHT SIDE HERNIAS. CLIENT EXPERIENCED SIGNIFICANT POSTOPERATIVE PAIN IN HIS ABDOMEN, PERSISTENT DISCOMFORT IN HIS GROIN, DIFFICULTY RISING FROM A SITTING AND LYING POSITION AS WELL AS RETURNING TO A LYING OR SITTING POSITION FROM A STANDING POSITION. OUR CLIENT ALSO NOTED NUMBNESS IN HIS THIGHS. OUR CLIENT'S ABDOMINAL PAIN PERSISTED AND ACCORDING TO NOTES ACCOMPANYING AN (B)(6) 2008 MRI, THE DOCTOR WRITES, "FOREIGN BODY REACTION TO MESH PLACEMENT OR A MESHOMA IS A POSSIBILITY." THE DOCTOR ALSO STATES IN HER IMPRESSION OF OUR CLIENT THAT THERE IS NO EVIDENCE OF A RECURRENT HERNIA AND THAT A REACTION TO MESH/MESHOMA SHOULD BE CONSIDERED. IN ADDITION TO THE DEBILITATING PHYSICAL PAIN, OUR CLIENT BEGAN SUFFERING FROM DEPRESSION, DUE TO THE FACT HE WAS LIVING IN CONSTANT PAIN AND DISCOMFORT, AND BECAUSE HE WAS UNABLE TO WORK AND PROVIDE FOR HIS FAMILY. OUR CLIENT LIVED WITH CONTINUED PAIN FOR A YEAR, SOUGHT PAIN TREATMENT AND MEDICAL ADVICE UNTIL HE WAS FINALLY ADMITTED TO (B)(6) HOSPITAL ON (B)(6) 2009 TO EXPLANT THE CR BARD MESH PERFIX PLUG. THE MESH WAS SUCCESSFULLY REMOVED AND REPLACED WITH ANOTHER MESH. SINCE THE (B)(6) 2009 SURGERY, OUR CLIENT IS STILL EXPERIENCING DEBILITATING PAIN, TENDERNESS AND REPORTS A HARD FORMATION IN THE AREA WHERE THE REPLACEMENT MESH WAS IMPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BARD PERFIX PLUG EXTRA LARGE, MONOFILAMENT KNITTED POLYPROPYLENE PERFIX PLUG EXTRA LARGE, MONOFILAMENT KNITTED POLYPROPYLENE FTL DAVOL INC. BARD MESH PERFIX HURE1574

Patients

Seq Age Sex Outcome Treatment
1 56 YR Hospitalization| R| S