FDA Adverse Event
Other
Summary report: N
INFINITY ENTERAL FEEDING BAG
MDR report key: 2592134
·
Received May 23, 2012
Report
- Report Number
- 1722139-2012-00748
- Event Type
- Other
- Date Received
- May 23, 2012
- Date of Event
- April 24, 2012
- Report Date
- April 25, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- KNT
- PMA / PMN Number
- K012147
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCTS WERE RETURNED FOR INVESTIGATION, UNABLE TO VERIFY THE COMPLAINT. DHR REVIEWED NO NON-CONFORMANCES RELATED TO PROVIDED LOT. NO INJURY ALLEGED BY PATIENT.
Description of Event or Problem · 1
CUSTOMER STATES: THE NEW STYLE OF BAGS STARTED HAVING PROBLEMS WITH NO FOOD AND NO FLOW IN CAUSING PATIENT HAD TO BE HOSPITALIZED FOR A SHORT PERIOD DUE TO NOT GETTING ENOUGH FOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITY ENTERAL FEEDING BAG | KNT | MOOG MEDICAL DEVICES GROUP | INF0500 | CF1132807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |