FDA Adverse Event
Other
Summary report: N
*
MDR report key: 329750
·
Received April 25, 2001
Report
- Report Number
- 1419377-2001-00002
- Event Type
- Other
- Date Received
- April 25, 2001
- Date of Event
- January 2, 2001
- Manufacturer
- AUTOMATIC LIQUID PACKAGING, INC.
- Product Code
- BTT
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
4/17/01 A HOSP WAS CONTRACTED BY AUTOMATIC LIQUID PACKAGING AND RPTR DIRECTED THE CALL TO ANOTHER PERSON, WHO FILED THE MDR FOR THE HOSP. THE OTHER PERSON RELAYED THAT THE ORIGINAL PRODUCT IN QUESTION HAD BEEN DISCARDED, AND NO LOT NUMBER HAD BEEN TAKEN FROM THE PRODUCT, WHICH IS REQUIRED BY AUTOMATIC LIQUID PACKAGING TO COMPLETE ANY INVESTIGATIVE REQUIREMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18968 | * | HUMIDIFIER BOTTLE 500ML | BTT | AUTOMATIC LIQUID PACKAGING, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |