3M¿ HEALTH CARE AURA¿ PARTICULATE RESPIRATOR AND SURGICAL MASK
Received Jan 16, 2018 · Event occurred Dec 29, 2017
Report 2110898-2018-00009 · MDR key 7195317
Device
Generic name
Surgical Apparel
Manufacturer
3m Health CareModel number
1870+Catalog number
1870+
Lot number
C172071
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
49 YR
- High Blood Pressure/ Hypertension
- Respiratory Distress
- Patient Problem/Medical Problem
- High Blood Pressure/ Hypertension
- Respiratory Distress
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
INFORMATION OBTAINED ON FEBRUARY 15, 2018 INDICATES: (B)(4) SAMPLES WERE RECEIVED AND VISUALLY REVIEWED WITH NO ABNORMALITIES OBSERVED, AND NO ABNORMAL ODOR NOTICED. COMPLAINTS WERE REVIEWED FROM COMPLAINTS WERE REVIEWED FROM JANUARY 1, 2016 TO DECEMBER 31, 2017; THERE HAS BEEN A TOTAL OF (B)(4) MEDICAL COMPLAINTS RECEIVED, WHERE ONE INVOLVED AN ANAPHYLACTIC REACTION IN ADDITION TO THIS CURRENT COMPLAINT. THE ADDITIONAL COMPLAINT DID NOT HAVE THE SAME LOT NUMBER AS THIS COMPLAINT. END OF REPORT.
Additional Manufacturer Narrative
PT IDENTIFIER AND WEIGHT: NO INFORMATION PROVIDED. THIS TYPE OF REPORTED EVENT IS RARE. THE PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX. THE DOCTOR MENTIONED THE STEROID GIVEN WAS PROBABLY SOLU-MEDROL (METHYLPREDNISOLONE). THE PRODUCT USED IS NO LONGER AVAILABLE AND WILL NOT BE SENT IN FOR EVALUATION. END OF REPORT.
Description of Event or Problem
AN OCCUPATIONAL HEALTH WORKER ALLEGED THAT A FEMALE, WHO IS A REGISTERED NURSE (RN), WORE A SURGICAL RESPIRATOR TO PERFORM PATIENT CARE FOR AN ISOLATION PATIENT. WITHIN THIRTY MINUTES OF WEARING THE SURGICAL RESPIRATOR, SHE BEGAN TO FEEL STRANGE AND THOUGHT SHE SMELLED LATEX IN THE SURGICAL RESPIRATOR. AFTER REMOVAL OF THE SURGICAL RESPIRATOR, THE RN CONTINUED TO FEEL UNWELL, WAS SEEN IN THE EMERGENCY ROOM, AND THEN ADMITTED TO THE HOSPITAL CRITICAL CARE UNIT, WHERE SHE REMAINED OVER THE WEEKEND. A MEDICAL DOCTOR WHO IS AN ALLERGIST CONTACTED 3M AND ALLEGED THAT THE RN EXPERIENCED ANAPHYLAXIS, WHERE THE SYMPTOMS INCLUDED SHORTNESS OF BREATH, THROAT TIGHTNESS, PROFUSE RHINORRHEA AND HYPOTENSION, WHICH RESULTED AFTER THE FIRST-TIME USE OF THIS TYPE OF SURGICAL RESPIRATOR WORN BY THE RN. THE RN WAS HOSPITALIZED THE SAME DAY ON (B)(6) 2017, AND WAS DISCHARGED ON (B)(6) 2017. SHE WAS GIVEN EPINEPHRINE, STEROIDS AND AN ANTIHISTAMINE IN THE EMERGENCY ROOM, AND THERAPY WAS CONTINUED WITH EPINEPHRINE AND STEROIDS DURING THE HOSPITAL STAY. THE CURRENT STATUS OF THE (RN) IS FINE ACCORDING TO THE DOCTOR.