MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-26 for INTRATEMP THERMABASIN DRAPE ITB100 manufactured by Haywood Vocational Opportunities.
| Report Number | 1043549-2019-40002 |
| MDR Report Key | 8831335 |
| Date Received | 2019-07-26 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-07-17 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-07-26 |
| 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 | ANULI OKOLO-YOUNG |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | ECOLAB |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55102 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTRATEMP THERMABASIN DRAPE |
| Generic Name | FLUID WARMING & SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2019-07-26 |
| Returned To Mfg | 2019-07-22 |
| Model Number | ITB100 |
| Lot Number | 79059 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAYWOOD VOCATIONAL OPPORTUNITIES |
| Manufacturer Address | 172 RIVERBEND ST. WAYNESVILLE NC 28786 US 28786 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-26 |