MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-20 for WARMTOUCH 501-5900 manufactured by Celsius Medical S.l..
[184261243]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184261244]
According to the reporter, the unit had a smell of burnt component. There was no allegation of patient death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00216 |
| MDR Report Key | 9859503 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2007-04-23 |
| Date Added to Maude | 2020-03-20 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | CELSIUS MEDICAL S.L. |
| Manufacturer Street | CTRA DE AJALVIR, KM 5, 200 |
| Manufacturer City | AJALVIR 28864 |
| Manufacturer Country | ES |
| Manufacturer Postal Code | 28864 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARMTOUCH |
| Generic Name | SYSTEM, THERMAL REGULATING |
| Product Code | DWJ |
| Date Received | 2020-03-20 |
| Model Number | 501-5900 |
| Catalog Number | 501-5900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELSIUS MEDICAL S.L. |
| Manufacturer Address | CTRA DE AJALVIR, KM 5, 200 AJALVIR 28864 ES 28864 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |