FDA Adverse Event Malfunction Summary report: N

MCGUIRE URINAL UNISIZE

MDR report key: 1343300 · Received January 29, 2009

Report

Report Number: 2183558-2009-00004
Event Type: Malfunction
Date Received: January 29, 2009
Date of Event: January 8, 2009
Report Date: January 8, 2009
Manufacturer: COLOPLAST MANUFACTURING US, LLC
Product Code: FNP
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US

Narratives

Additional Manufacturer Narrative · 1

THE RETURN OF THE DEVICE HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE IS STILL AVAILABLE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, AN ADDENDUM TO THIS REPORT WILL BE FILED. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT NUMBER.

Description of Event or Problem · 1

AN END-USER'S DAUGHTER REPORTED AN ISSUE WITH THE PRODUCT SHE HAD PURCHASED FOR HER FATHER IN EARLY 2009. HE USED IT THAT NIGHT ALONG WITH A BARDIA BAG (PROD. NOT LOT NUMBER AVAILABLE). WHEN HE WOKE UP, THE SHEATH WAS SUCTIONING AROUND THE PENIS SO THAT IT WAS ALMOST COMPLETELY FLATTENED. WHEN THEY REMOVED THE MCGUIRE, THE PENIS WAS SWOLLEN TO ALMOST 3 TIMES THE NORMAL SIZE AND BROKEN BLOOD VESSELS WERE VISIBLE. THERE WAS VERY LITTLE URINE IN THE COLLECTION BAG, BUT PATIENT'S DAUGHTER REPORTED THEY HAD USED THAT EXACT BARDIA BAG FOR 2 WEEKS WITH MECS AND DID NOT HAVE AN ISSUE WITH IT, SO IT DIDN'T APPEAR TO BE A DEFECT IN THE BAG. PATIENT CLAIMS HE IS NOT IN PAIN, BUT MAY DECIDE TO GO TO URGENT CARE IF THE SWELLING DOES NOT GO DOWN. A COMPLAINT WAS FILED AND PATIENT IS SENDING DEFECTIVE PRODUCT BACK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MCGUIRE URINAL UNISIZE	URINE COLLECTOR	FNP	COLOPLAST MANUFACTURING US, LLC	5070701400	1578320

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	BARDIA BAG