inforMED
InjuryIFP

SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE

Received Oct 22, 2019 · Event occurred Aug 9, 2017

Report 1831638-2019-00005 · MDR key 9219024

Device

Generic name

10% Formalin

Model number

561201

Catalog number

561201

Lot number

UNKNOWN

Product problems

  • Device Markings/Labelling Problem

Patient

Not reported

  • Pain
  • Injury
  • Pain
  • Injury

Narrative

Description of Event or Problem

PLANTIFF ALLEGES THAT ON OR ABOUT (B)(6) 2017, SHE WAS INJURED WHEN SHE OPENED AN UNMARKED BOX CONTAINING A BAG WITH "BROKEN CONTAINERS" CONTAINING AND "UNKNOWN CHEMICAL". AS SHE OPENED THE BAG, SHE SAW THE BROKEN CONTAINERS AND INHALED THE UNKNOWN CHEMICAL, ALLEGEDLY CAUSING HER INJURY. SHE CLAIMS UNSPECIFIED BODILY INJURIES, MEDICAL EXPENSES, LOST EARNINGS, AND PAIN AND SUFFERING. PLAINTEFF ALLEGES THAT DEFENDANTS FAILED TO PROPERLY HANDLE AND PROPERLY LABEL THE BOX, WHICH THEY HAD PREVIOUSLY HANDLED/TRANSPORTED. RESPIRATORY IMPACT WAS THE ONLY INJURY NOTED IN THE COMPLAINT.