ARIS TRANS-OBTURATOR

MDR report key: 3842776 · Received January 24, 2014

Report

Report Number: 2125050-2014-00107
Event Type: Injury
Date Received: January 24, 2014
Date of Event: January 18, 2012
Report Date: January 23, 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 MESH EROSION, PERSISTED URINARY INCONTINENCE, MILD BURNING WITH URINATION, LOWER BACK PAIN, PYURIA, NEW ONSET URGE, CRAMPING AND BLEEDING WITH SEXUAL ACTIVITY. AN EXCISION OF THE MESH AND CYSTOSCOPY WERE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
55885	ARIS TRANS-OBTURATOR	POLYMERIC SURGICAL MESH	FTL	COLOPLAST A/S	5195511400	2496644

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other