FDA Adverse Event
Death
Summary report: N
MALLINCKRODT NEBULIZER WITH ADULT AEROSOL MASK
MDR report key: 4199224
·
Received October 22, 2014
Report
- Report Number
- 3000219639-2014-00009
- Event Type
- Death
- Date Received
- October 22, 2014
- Report Date
- October 22, 2014
- Manufacturer
- SALTER LABS
- Product Code
- CAF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2014 SALTER LABS WAS INFORMED OF AN INCIDENT OF DEVICE MODEL NUMBER 13962, MALLINCKRODT NEBULIZER WITH ADULT AEROSOL MASK 2.1 M SUPPLY TUBE, ELASTIC STRAP FIXATION, UNIVERSAL CONNECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670801 | MALLINCKRODT NEBULIZER WITH ADULT AEROSOL MASK | MALLINCKRODT NEBULIZER | CAF | SALTER LABS | 13962 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |