DMA ONE-SHOTS HDL PRECIPITATING REAGENT 3335

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-12-05 for DMA ONE-SHOTS HDL PRECIPITATING REAGENT 3335 manufactured by Data Medical Associates, Inc. (dma).

Event Text Entries

[35775] On 11/7/96, pt called co's technical support to ask if hdl precipitating reagent could cause a skin rash. As technical support discussed situation with customer, pt said that she had developed a rash on the outside surface of the thumb of her left hand at about same time she started running hdl cholesterol assays (7/96). She had read the procedure sheet warning and msds and inquired about product warnings of irritation. Technical support told her that while co personnel had not experienced any reactions to this product, every person reacts according to their own unique systems. 1. Sometimes pt wears latex gloves (non-powedred) and sometimes she does not. She uses non-powdered gloves because she is allergic to glove talc. She was informed that some people develop allergies to latex and perhaps she might want to try vinyl gloves. She said that she had some info on latex allergies. 2. When pt was asked if she had gotten any reagent on her hands, she said while she could not say for certain that she had, she felt that it was very possible and that even with wearing gloves, their gloves weren't very good and there was a possibility that at some time, reagent had come in contact with her skin. 3. When pt had consulted one of the drs she works with about the skin rash, and he was treating it as contact dermatitis. She was wearing a finger cot under her gloves, changing gloves between chemistries, washing her hands and applying vaseline to the rash while at work. At home, at night, she was applying a steroid cream to the rash and wearing some type of glove over the rash. 4. At first in (7/96) pt and her dr thought that rash was some type of "weed rash" due to plant contact outside work. Since rash had persisted beyond any time of plant contact, she said that she and the dr were checking for any other possible causes for rash and that was the reason for the call to co. She also said that the rash got better when she was not running cholesterol assays and it got worse when she was running them. 5. Pt had copies of the procedure sheet and msds sheet for the product concerned and was aware of the product warning to avoid contact with eyes, skin, and clothing. 6. When pt was asked if she had inquired about rash to other reagent mfrs, she said that she had not, and that she felt the rash was due to contact with the hdl precipitating reagent contained in one shot microcentrifuge tubes. 7. Pt asked about pg of the 3334 hdl precipitating reagent and she was told that tit is 5. 3. 8. On 11/12/96, co's regulatory called the clinic where pt works to talk with dr. (the dr pt works with who is also treating the alleged rash). Dr said that he did not know at this point in time. Dr said that pt had not been wearing gloves when rash appeared. She has since started wearing gloves when handling the reagent but rash has not clared up. Both dr and pt were advised to contact co if they needed any further assistance, or info.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1650060-1996-00001
MDR Report Key53811
Report Source05
Date Received1996-12-05
Date of Report1996-12-03
Date of Event1996-11-07
Date Mfgr Received1996-11-07
Device Manufacturer Date1995-12-01
Date Added to Maude1996-12-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDMA ONE-SHOTS HDL PRECIPITATING REAGENT
Generic NameINVITRO DEVICE FOR PRECIPITATING HDL
Product CodeLBS
Date Received1996-12-05
Model NumberNA
Catalog Number3335
Lot NumberLJ09
ID NumberNONE
Device Expiration Date1997-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key54400
ManufacturerDATA MEDICAL ASSOCIATES, INC. (DMA)
Manufacturer Address845 AVE G EAST ARLINGTON TX 76011 US
Baseline Brand NameDMA ONE-SHOTS HDL PRECIPITATING REAGENTS
Baseline Generic NameHDL CHOLESTEROL PRECIPITATING REAGENT
Baseline Model NoNA
Baseline Catalog No3335
Baseline IDLJ09
Baseline Device FamilyHDL PRECIPITATING REAGENT
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK781165
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1996-12-05

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