FDA Adverse Event Injury Summary report: N

PERFIX PLUG

MDR report key: 2895293 · Received November 20, 2012

Report

Report Number: 1213643-2012-00823
Event Type: Injury
Date Received: November 20, 2012
Report Date: October 23, 2012
Manufacturer: DAVOL INC.
Product Code: FTL
PMA / PMN Number: K922916
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

WE ARE UNABLE TO CONTACT THE INITIAL REPORTER AS NO CONTACT INFO WAS PROVIDED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT REPORTS PAIN AND THAT THE PERFIX PLUG WAS EXPLANTED. CURRENTLY, MEDICAL RECORDS, PRODUCT IDENTIFIERS AND A SAMPLE HAS NOT BEEN PROVIDED. WITH THE LIMITED INFO, NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem · 1

THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT ((B)(4)). "AFTER WAITING TWO MONTHS FOR SURGERY THROUGH CHARITY CARE, THE INGUINAL HERNIA BECAME LARGE ENOUGH THAT SURGERY BECAME IMMEDIATELY NECESSARY. THE SURGEON RUSHED THE SURGERY, USED A PERFIX PLUG AND MARLEX MESH TO REPAIR THE HERNIA. THE NEXT TWO YRS WERE FILLED WITH DAILY PAIN IN THE AREA OF SURGERY UNTIL IT WAS TO THE POINT WHERE I COULDN'T FUNCTION WITH IT. AFTER CONSULTING HALF A DOZEN SPECIALISTS, NO ONE WANTED TO PERFORM SURGERY TO FIX THIS SITUATION, BECAUSE THEY DIDN'T WANT THE RESPONSIBILITY OF FIXING ANOTHER SURGEON'S MESS. FINALLY, I FOUND A DOCTOR. HE HAD PERFORMED SURGERY TO TAKE OUT THE PLUG, WHICH WAS LARGER THAN A GOLD BALL WITH SCAR TISSUE WHEN REMOVED. I STILL HAVE MANY ISSUES WITH THE AREA, AND HAVE TROUBLE PERFORMING SEXUALLY BECAUSE OF THE TREMENDOUS DISCOMFORT THAT IS STILL THERE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PERFIX PLUG		FTL	DAVOL INC.	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI		Required Intervention\| S