MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-24 for READY-HEAT S2RHIM manufactured by Techtrade Llc.
| Report Number | 3005346101-2019-00001 |
| MDR Report Key | 9233890 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-24 |
| Date of Report | 2019-10-22 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2019-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS ERIN BART |
| Manufacturer Street | 30 MONTGOMERY ST. STE. 690 |
| Manufacturer City | JERSEY CITY NJ 07302 |
| Manufacturer Country | US |
| Manufacturer Postal | 07302 |
| Manufacturer Phone | 2017068130 |
| Manufacturer G1 | TECHTRADE LLC |
| Manufacturer Street | 720 EAST BROADWAY |
| Manufacturer City | FORTVILLE IN 46040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | READY-HEAT |
| Generic Name | READY-HEAT INFANT WARMING MATTRESS |
| Product Code | KME |
| Date Received | 2019-10-24 |
| Model Number | S2RHIM |
| Lot Number | 18183M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECHTRADE LLC |
| Manufacturer Address | 30 MONTGOMERY ST. STE. 690 JERSEY CITY NJ 07302 US 07302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2019-10-24 |