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 2017-12-27 for WARMER DRAPE ORS-300 manufactured by Microtek Dominicana, S.a..
[96225617]
The dhr was reviewed and it was noticed that this lot had (b)(4) cases that were manufactured from 6/22/2017 to 6/25/2017. No defects were reported during quality inspections. At the time of this report, the device had not been returned for evaluation. As no device was available for evaluation, the root cause of this complaint cannot be confirmed. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96225618]
Per company rep: "staff member noticed significant amount of fluid under drape at the end of the procedure. Filed a complaint form internally. Materials manager notified me and gave me the compromised drape. " no patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2017-00034 |
| MDR Report Key | 7148662 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-27 |
| Date Mfgr Received | 2017-12-27 |
| Date Added to Maude | 2017-12-27 |
| 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 | WARMER DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2017-12-27 |
| Model Number | ORS-300 |
| Lot Number | D171721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-27 |