MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for READY HEAT INFANT WARMING MATTRESS S2RHIM manufactured by Tech Trade Llc.
| Report Number | MW5090088 |
| MDR Report Key | 9130368 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-09-12 |
| Date Added to Maude | 2019-09-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | READY HEAT INFANT WARMING MATTRESS |
| Generic Name | BEDDING, DISPOSABLE, MEDICAL -READY-HEAT |
| Product Code | KME |
| Date Received | 2019-09-27 |
| Model Number | S2RHIM |
| Lot Number | 18183M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECH TRADE LLC |
| Manufacturer Address | JERSEY CITY NJ 07302 US 07302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2019-09-27 |