FDA Adverse Event
Injury
Summary report: N
3M 1870 HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
MDR report key: 1013163
·
Received March 12, 2008
Report
- Report Number
- 2110898-2008-00004
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- February 20, 2008
- Report Date
- March 5, 2008
- Manufacturer
- 3M HEALTH CARE
- Product Code
- FXX
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER SAVED THE MASK BUT DISPOSED THE REST OF THE LOT. THE CUSTOMER DID NOT RETURN THE MASK, SO 3M DID NOT CONDUCT DEVICE EVALUATION. THE CUSTOMER STATED HE THINKS THE INCIDENT WAS NOT RELATED TO THE MASK BECAUSE THE EMPLOYEE (NURSE) HAD A FEVER AND A LUNG INFECTION.
Description of Event or Problem · 1
CUSTOMER REPORTED A NURSE ADMITTED TO THE ER WITH LARYNGEAL EDEMA, TIGHTNESS IN THE CHEST AND SHORTNESS OF BREATH AFTER WEARING THE 3M 1870 SURGICAL MASK FOR 3 DAYS. REPORTEDLY, SHE WAS TREATED WITH AN EPI NEBULIZER AND INJECTION, SOLUMEDROL IV, AND COOL AEROSOL THERAPY AND THEN DISCHARGED ON A PREDNISONE TAPER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M 1870 HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK | SURGICAL MASK | FXX | 3M HEALTH CARE | 1870 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |