MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-09-19 for PRISM HEALTHCARE 20421 manufactured by .
[20545435]
A review of our complaint database uncovered no similar complaints or mdrs regarding the subject device; however, three mdrs were filed with regards to similar products, i. E. Infant heel warmers (reference list attached). The transport mattress and the heel warmer both contain the same solution, food grade sodium acetate, water and thickeners. These previous events are not similar in nature to the subject event, therefore, the subject event is not considered part of a trend. There have been no design changes since this product was marketed relating to this event. Once activated, the transport mattress is expected to provide heat for up to two hours. There are no complaints indicating the mattress failed to stay warm for the anticipated two hours. With regards to this event, the instructions for use, located on the device, in statement 6 states to check the infant's skin occasionally for redness and core temperature. The 0transport mattress was used in conjunction with external heat sources.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00017 |
| MDR Report Key | 952902 |
| Report Source | 00 |
| Date Received | 2007-09-19 |
| Date Added to Maude | 2007-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM HEALTHCARE |
| Generic Name | INFANT TRANSPORT MATTRESS |
| Product Code | FOH |
| Date Received | 2007-09-19 |
| Model Number | 20421 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 860926 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-19 |