MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-01 for ORS-320 SLUSH WARMER DISC DRAPE manufactured by Microtek Dominicana, S.a..
[107573420]
Numerous attempts were made to contact the customer to obtain the sample but a response was not received. The dhr was reviewed and it was confirmed that lot d172361 had (b)(4) cases that were manufactured from 08/24/17 to 08/26/17. No defects were reported during quality inspection. Based on the device history record this does not appear to be the result of a personnel, process or material issue. Since no sample was provided the non conformity could not be confirmed. No additional actions will be taken at this time. A follow up report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[107573421]
During case, circulator noticed saline in warmer not contained in sterile drape. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00014 |
| MDR Report Key | 7476239 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-02-14 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-01 |
| 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 | MRS JENNIFER MRKVICKA |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK DOMINICANA |
| Manufacturer Street | ZONA FRANCA NO. 2 |
| Manufacturer City | LA ROMANA, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORS-320 SLUSH WARMER DISC DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-05-01 |
| Model Number | ORS-320 |
| Lot Number | D172361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |