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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DWK LIFE SCIENCES LLC LABORATORY BURET KIMAX KG33 KIMBLE; TUBE, COLLECTION, CAPILLARY BLOOD

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DWK LIFE SCIENCES LLC LABORATORY BURET KIMAX KG33 KIMBLE; TUBE, COLLECTION, CAPILLARY BLOOD Back to Search Results
Model Number 17026F10
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Dyspnea (1816); Visual Impairment (2138); Toxicity (2333); Injury (2348); Cognitive Changes (2551)
Event Date 10/17/2017
Event Type  Injury  
Event Description
Inflammation neurotoxin; laboratory accident involving borosilicate glass tubing product article made from kg 33 catastrophic failure severe dermal injury glass needle like slivers in spine area and shoulder severe lung injury from respirable bioactive silica metal oxide nanoparticles.I'm not seeking pain pills i'm seeking treatment to get better.Recent development of systemic toxicity including endocrine disruption neurological disruption metabolic disruption cognitive issues and severe degradation of vision.I was extremely healthy and very physically fit and active ran 5 miles a day cannot function due to injury from glass slivers in the spine area and breathing issues from a long injury acute silicosis from massive respirable exposure to make silica dust including multiwall carbon nanotubes and metal oxide particles, having severe systemic toxicity issues and in desperate need of medical treatment.Willing to travel if necessary to find an appropriate medical doctor or clinic.Fda safety report id # (b)(4).
 
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Brand Name
LABORATORY BURET KIMAX KG33 KIMBLE
Type of Device
TUBE, COLLECTION, CAPILLARY BLOOD
Manufacturer (Section D)
DWK LIFE SCIENCES LLC
MDR Report Key10188768
MDR Text Key196409305
Report NumberMW5095160
Device Sequence Number1
Product Code GIO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number17026F10
Device Catalogue Number17026F10
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/23/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention; Disability;
Patient Age43 YR
Patient Weight59
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