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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP. LATEX GLOVES   back to search results
Catalog Number 8877
Patient Outcome  Required Intervention; Disability
Event Description

Rptr has been a nurse tech for 4 1/2 years, starting work in the hosp. Two yrs later rptr experienced an allergy reaction, ie, contact dermatitis, runny nose, itchy, watery eyes, sneezing and coughing. These symptoms are still occurring. Rptr filed 1st incident report for worker's compensation. Rptr was treated by hosp md for 2 yrs, only with cortisone cream for the hands. However, rptr also experienced hives, inflamed eyes, visual impairment, sob, dry, scratchy throat and coughing. There was no paperwork follow-up done by the md or worker's compensation nurse so the rptr's claim was closed. However, rptr's symptoms continued. Rptr states that the hosp did a blood test but the blood was not tested in the proper lab, so the test results were negative. Rptr also states that the worker's compensation md laughed at rptr and "blew them off" for over 2 years. Rptr was never given non-latex gloves. As the 2 years went by rptr had to reduce work hrs due to fatigue. Rptr was also ingesting powder from the gloves. Rptr states that during the early part of 2000, the hosp was sold. Rptr filed a 2nd worker's compensation report. A new insurance co was involved with the hosp after its sale and the new co reopened the worker's compensation case. However, when the new co realized the former co had closed the case, the new co said the condition was pre-existing. The new co closed the case. Rptr has seen 2 allergists, both of whom have confirmed (chronic) latex allergy, for which there is no cure, only strict avoidance of latex products. The 1st allergist rptr saw performed a true test which was positive for natural latex rubber. Rptr also had blood work done 1 week ago. Rptr has hired an atty to try to obtain worker's compensation. Rptr states they have to be careful in restaurants. If food is prepared using latex gloves, rptr could have an anaphylactic reaction. Rptr carries an epipen and an inhaler and is on new medications due to latex allergy. Rptr has applied for disability. Rptr's atty has filed suit with the hosp. Rptr states that the latex material and the powder are deadly, but that if hosps have to provide non-latex or powder-free gloves, it causes a big problem.

 
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Type of DeviceLATEX GLOVES
Baseline Brand NamePOSITIVE TOUCH PF LATEX EXAM GLOVES
Baseline Generic NamePF LATEX EXAM GLOVES
Baseline Catalogue Number8877
Baseline Model Number8877
Baseline Device FamilyPF LATEX EXAM GLOVES
Baseline Device 510(K) NumberK012149
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed09/24/2001
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP.
mcgaw park IL 60085
Device Event Key288997
MDR Report Key298553
Event Key280444
Report NumberMW1020039
Device Sequence Number1
Product CodeLYY
Report Source Voluntary
Report Date 09/29/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Invalid Data
Device Catalogue Number8877
OTHER Device ID Number10-2327B, 10-2327C
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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