MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-03-13 for ORS-100N WARMER DRAPE manufactured by Microtek Dominicana, S.a..
[102327545]
The sample received was evaluated. A small cut/hole was observed about 5 1/2 inches from the center of the drape. This looks to have been caused by a sharp of some sort. The dhr was reviewed and it was noticed that this lot had 95 cases that were manufactured from 06/21/2016 to 06/22/2016. No defects were reported during quality inspections. This is a non sterile part that is supplied to a kit packer for further packaging and sterilization. Based on the device history record and sample review, this does not appear to be the result of a personnel, process or material issue. Because this appears to be related to misuse by the customer, no actions are being taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[102327546]
A customer is reporting a complaint from a hospital stating that they received a fluid warmer drape that contained a hole within the drape. The sample was received by the customer and the reported concern was confirmed. A small tear within the plastic was noted and upon examining the location of the drape, it was noted that there was nothing sharp next to the drape that could have caused such a tear. Also, the drape is received folded and is placed within the kit as such.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00007 |
| MDR Report Key | 7335774 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-19 |
| Date Mfgr Received | 2018-02-19 |
| Date Added to Maude | 2018-03-13 |
| 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-100N WARMER DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-03-13 |
| Returned To Mfg | 2018-03-05 |
| Model Number | ORS-100N |
| Lot Number | D161731 |
| 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 | 2018-03-13 |