FDA Adverse Event Other Summary report: N

URINAL

MDR report key: 1961735 · Received January 12, 2011

Report

Report Number: 1043646-2010-00002
Event Type: Other
Date Received: January 12, 2011
Date of Event: December 5, 2010
Report Date: January 12, 2011
Manufacturer: MEDEGEN MEDICAL PRODUCTS
Product Code: FNP
PMA / PMN Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT WAS REC'D FROM (B)(4) TERRITORY MGR AT THE COMPLAINT UNIT FOR MEDEGEN MEDICAL PRODUCTS ON (B)(4) 2010 AND WAS IMMEDIATELY ASSIGNED COMPLAINT (B)(4). (B)(6) WAS CONTACTED FOR MORE INFORMATION AND TO RETRIEVE THE COMPLAINED URINAL. INVESTIGATION: NO FURTHER INFORMATION WAS GIVEN ON THE CONDITION OF THE PT AND THE LOT NUMBER WAS UNK. THE COMPLAINED URINAL WAS VISUALLY INSPECTED AND THE RUBBER GLOVE TEST AS ADMINISTERED PER SPECIFICATION NUMBER (B)(4). THE GLOVE TEST CONSISTED OF: RUBBING GLOVED HAND AROUND AND ACROSS THE OUTSIDE/INSIDE URINAL CHECKING FOR SHARP EDGES AND PROTRUSIONS THAT MAY PUNCTURE A SURGICAL GLOVE. THE GLOVE USED ON THE COMPLAINED URINAL SHOWED NO TEARS, SNAGS OR DRAG MARKS. CONCLUSION: THERE WERE NO PROTRUSIONS OR SHARP EDGES FOUND ON THE COMPLAINED URINAL AND WE ARE UNABLE TO ASCERTAIN HOW THE URINAL CUT THE PT WITHOUT FURTHER PT INFORMATION. QUALITY ASSURANCE WILL CONTINUE TO PERFORM VISUAL INSPECTIONS/(B)(4) ONCE EVERY HOUR PER SHIFT PER SPECIFICATION NUMBER (B)(4), AND WILL CONTINUE TO MONITOR FOR THIS DEFECT AND ADDRESS INDIVIDUAL COMPLAINTS.

Description of Event or Problem · 1

IT WAS REPORTED THAT SHARP EDGE OF A URINAL CUT A PT. NO FURTHER INFORMATION ON THE PTS CONDITION HAS BEEN MADE AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		URINAL	FNP	MEDEGEN MEDICAL PRODUCTS	H140D-01	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other