NIC BOWEL MANAGEMENT KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-01 for NIC BOWEL MANAGEMENT KIT manufactured by Medical Innovations, Inc..

Event Text Entries

[8143] Pt is a 13 1/2-yr-old young man who has a latex sensitivity. He's post meningomyelocele repair at a young age. He has problems with both his bladder and bowels and has to have bladder catheterization as well as enemas. Three wks ago he had an episode of hives on the right side of his face, trunk and arms, with some throat tightness. These symptoms came on approx 15 mins after he had an enema. His mother called dr on 8/9 noting that the night before his father had been giving him an enema and had inserted the tubing and had just blown up the balloon when he broke out with hives on his scalp, face, trunk and arms. The catheter was immediately removed but within mins he complained of throat tightness. Epinephrine was given. He had not eaten anything for four to five hrs prior to the second reaction, although prior to the first reaction there was some concern that he may have had some food but since he was at a camp mother wasn't sure of the exact contents of the food. According to co, the material is 100% silicone. So checked with subcontractor and they reportedly did not have any latex that the catheter could have come in contact with. Dr has since learned that the elastomers used in the balloons apparently can change their content, depending on what is available at what price. It is critical to know if there is any chance at all that latex could somehow have worked into the situation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000158
MDR Report Key11305
Date Received1994-02-01
Date of Report1993-08-18
Date Added to Maude1994-02-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNIC BOWEL MANAGEMENT KIT
Product CodeFCE
Date Received1994-02-01
OperatorLAY USER/PATIENT
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11305
ManufacturerMEDICAL INNOVATIONS, INC.
Manufacturer AddressMILPITAS CA 95035 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-01

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