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 2018-05-07 for WARMER DRAPE ORS-300 manufactured by Microtek Dominicana, S.a..
[107581203]
A sample was received for investigation. The sample drape was placed over a warmer and water was added. The drape was left on the warmer for over 1 hour. No leaks, tears, holes or burn marks were found. The dhr was reviewed for lot d173059 and it was noticed that this lot had 2736 pieces that were manufactured on 11/02/2017. No defects were reported during quality inspections. Based on the device history record and sample review, this does not appear to be the result of a personnel, process, or material issue as no leaks, tears, holes or burn marks were found. Since the reported issue was not found review of the sample and no defects were reported during quality inspection, no additional actions will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[107581204]
Company rep reported "drape is tearing during cases. Did not specify origins of tearing but that they considered double draping as a solution. I did let them know this is not a good idea and could lead to more issues. " no patient injury or treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00015 |
| MDR Report Key | 7492348 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2018-05-07 |
| 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 | 2018-05-07 |
| Returned To Mfg | 2018-04-27 |
| Model Number | ORS-300 |
| Lot Number | D173059 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-05-07 |