MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for PENGUIN MILK WARMING BAGS C124106 manufactured by Creche Innovations/neonatal Product Group Inc..
[63948685]
Leaking of penguin milk warming bags reported. There are 2 compartments, one for water and one for feeding syringe/bottle. The water compartment is leaking into the dry side possibly contaminating the babie's food source.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067021 |
| MDR Report Key | 6221673 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-12-12 |
| Date Added to Maude | 2017-01-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PENGUIN MILK WARMING BAGS |
| Generic Name | BOTTLE, HOT/COLD WATER - WARMER |
| Product Code | FPF |
| Date Received | 2016-12-29 |
| Model Number | C124106 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CRECHE INNOVATIONS/NEONATAL PRODUCT GROUP INC. |
| Manufacturer Address | STIWELL KS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-29 |