3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
Received Mar 28, 2018 · Event occurred Mar 19, 2018
Report 2110898-2018-00037 · MDR key 7379762
Device
Generic name
Surgical Respirator
Manufacturer
3m Health CareModel number
NACatalog number
1860
Lot number
UNK
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Anaphylactic Shock
- Anaphylactic Shock
Narrative
Additional Manufacturer Narrative
NO LOT NUMBER WAS PROVIDED- WITHOUT THE LOT NUMBER, WE CAN NOT DETERMINE THE UDI, EXPIRATION DATE AND MANUFACTURING DATE. NO SAMPLE WAS RETURNED FOR ANALYSIS. THE 3M SURGICAL RESPIRATOR IS NOT MADE WITH NATURAL RUBBER LATEX. THE USER FACILITY IS INVESTIGATING TO CONFIRM THE DIAGNOSIS AND OTHER POTENTIAL SOURCES OF LATEX THAT THE PATIENT MAY HAVE BEEN EXPOSED TO. END OF REPORT.
Description of Event or Problem
A FEMALE EMPLOYEE EXPERIENCED AN ANAPHYLACTIC REACTION AND ALLEGED THAT IT COULD BE DUE TO A 3M SURGICAL RESPIRATOR. NO INFORMATION REGARDING MEDICAL INTERVENTION WAS PROVIDED.