ARIS TRANS-OBTURATOR

MDR report key: 3840773 · Received January 30, 2014

Report

Report Number: 2125050-2014-00137
Event Type: Injury
Date Received: January 30, 2014
Date of Event: February 21, 2012
Report Date: January 30, 2014
Manufacturer: COLOPLAST A/S
Product Code: FTL
PMA / PMN Number: K050148
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFO CONTAINED IN THIS REPORT.

Description of Event or Problem · 1

AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PT WAS IMPLANTED WITH ARIS MESH. LATER THE PT EXPERIENCED EXPOSED MESH EROSION AND EXTRUSION, INFECTION, SMALL PART OF THE BLADDER SEEN IN THE VAGINAL VAULT, URGE INCONTINENCE, DYSPAREUNIA, OCCASIONAL FECAL INCONTINENCE, PELVIC PAIN, URINARY TRACT INFECTION AND STAGE 2 RECTOCELE. EXCISIONS OF THE MESH AND RECLOSURE OF INCISION WERE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
64636	ARIS TRANS-OBTURATOR	POLYMERIC SURGICAL MESH, PRODUCT CODE: FTL	FTL	COLOPLAST A/S	5195511400	2377700

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other