FDA Adverse Event
Injury
Summary report: N
MOJO FULL FACE MASK
MDR report key: 2573292
·
Received November 22, 2011
Report
- Report Number
- 1222088-2011-00001
- Event Type
- Injury
- Date Received
- November 22, 2011
- Date of Event
- October 4, 2011
- Report Date
- October 4, 2011
- Manufacturer
- SLEEPNET CORPORATION
- Product Code
- BZD
- PMA / PMN Number
- K060273
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO NOT INCLUDED IN DISTRIBUTOR'S REPORT. ADD'L INFO REGARDING PT DESCRIPTION OF ALLERGIC REACTION INCLUDED.
Description of Event or Problem · 1
ON (B)(4), 2011, SLEEPNET WAS NOTIFIED BY CAREFUSION THAT THEY "RECEIVED A REPORT OF A MOJO VENTILATED FULL FACE MASK CAUSING AN ALLERGIC REACTION ON A PT." A COPY OF THE MEDWATCH FORM SUBMITTED BY CAREFUSION WAS INCLUDED WITH THE NOTIFICATION. (CAREFUSION REPORT# 2050001-2011-00001). PER SLEEPNET'S CONVERSATION WITH THE INITIAL REPORTER AFTER RECEIVING NOTIFICATION FROM CAREFUSION, THE MASK "CREATED LITTLE WHITE BUMPS AROUND NOSE AND MOUTH THAT GOT OOZY." PT RECEIVED MASK ON (B)(6) 2011, REPORTED PROBLEM ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOJO FULL FACE MASK | CPAP MASK | BZD | SLEEPNET CORPORATION | 50836 | 50013705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |