MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-10 for FLUID WARMING AND SLUSH DRAPES ORS-320 manufactured by Ecolab / Microtek Dominicana, S.a..
[130060829]
It was reported that during the procedure, a hole was observed when fluid was leaking through the drape. The drape was replaced. No patient complications have been reported as a result of this event
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-40015 |
| MDR Report Key | 8147125 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-10 |
| Date of Report | 2018-11-04 |
| Date of Event | 2018-10-28 |
| Date Added to Maude | 2018-12-10 |
| 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 | 3 |
| Brand Name | FLUID WARMING AND SLUSH DRAPES |
| Generic Name | FLUID WARMING & SLUSH DRAPE, PRODUCT CODE: LHC |
| Product Code | LHC |
| Date Received | 2018-12-10 |
| Model Number | ORS-320 |
| Lot Number | D182129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB / MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-10 |