FDA Adverse Event
Injury
Summary report: N
ENTERALITE AMBULATORY ENTERAL FEEDING PUMP
MDR report key: 1731149
·
Received June 16, 2010
Report
- Report Number
- 1722139-2010-00068
- Event Type
- Injury
- Date Received
- June 16, 2010
- Date of Event
- April 21, 2010
- Report Date
- June 14, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K954735
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
REPORTED BY THE CUSTOMER AS: PARENT IS REPORTING THE PUMP HEATS UP WHILE IN BACKPACK TO THE POINT THE FORMULA GETS HOT AND BACTERIAL MATTER BUILDS UP CAUSING THE CHILD TO BECOME ILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERALITE AMBULATORY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP | ENTERALITE PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |