FDA Adverse Event
Other
Summary report: N
PREVENTION PLUS CHEMO ISOLATION GOWN
MDR report key: 2362240
·
Received November 30, 2011
Report
- Report Number
- 1417592-2011-00060
- Event Type
- Other
- Date Received
- November 30, 2011
- Date of Event
- October 27, 2011
- Report Date
- November 30, 2011
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- FME
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
WHEN THE CLINICIAN PUT ON THE GOWN, SHE IMMEDIATELY EXPERIENCED A RASH AROUND HER MOUTH AND ON HER FACE. SHE ALSO HAD DIFFICULTY BREATHING. SHE IS A KNOWN ASTHMATIC WITH MULTIPLE ALLERGIES. SHE USED HER INHALER, WAS SEEN BY THE OCCUPATIONAL HEALTH PRACTITIONER AND THEN GIVEN AN ANTIHISTAMINE WITH GOOD RESULTS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NOT RECEIVED ANY OTHER SIMILAR COMPLAINTS FOR THIS PRODUCT. NO CORRECTIVE ACTION IS INDICATED AT THIS TIME.
Description of Event or Problem · 1
A CLINICIAN DEVELOPED A SEVERE ALLERGIC REACTION AFTER PUTTING ON THE GOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREVENTION PLUS CHEMO ISOLATION GOWN | ISOLATION GOWN | FME | MEDLINE INDUSTRIES, INC. | NON27457M | 1051824992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |