inforMED
InjuryMSH

3M 1860 REPROCESSED BY BATTELLE N95 RESPIRATOR

Received Jun 23, 2020 · Event occurred Jun 19, 2020

Report MW5095190 · MDR key 10189635

Device

Generic name

Respirator, Surgical

Manufacturer

Unknown

Model number

1860S

Lot number

B20615

Product problems

  • Product Quality Problem

Patient

26 YR

  • Dyspnea
  • No Code Available
  • Dyspnea
  • No Code Available

Narrative

Description of Event or Problem

THE STAFF MEMBER DONNED A 3M 1860 SMALL N95 MASK THAT HAD RECENTLY BEEN REPROCESSED BY THE BATTELLE DECONTAMINATION SYSTEM. ALL GUIDELINES WITH REGARD TO DECONTAMINATED MASKS WERE FOLLOWED. UPON DONNING THE MASK, THE STAFF MEMBER NOTED HER ASTHMA SYMPTOMS WERE TRIGGERED AS SHE HAD SHORTNESS OF BREATH AND A COUGH. THESE SYMPTOMS RESOLVED AFTER REMOVAL OF THE MASK. 3M US. FDA SAFETY REPORT ID #: (B)(4).