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

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).

• Brand Name: LABORATORY BURET KIMAX KG33 KIMBLE
• Type of Device: TUBE, COLLECTION, CAPILLARY BLOOD
• Manufacturer (Section D): DWK LIFE SCIENCES LLC
• MDR Report Key: 10188768
• MDR Text Key: 196409305
• Report Number: MW5095160
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 17026F10
• Device Catalogue Number: 17026F10
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 43 YR
• Patient Weight: 59