MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-14 for 2100A manufactured by Lw Scientific, Inc..
[94842538]
Patient Sequence No: 1, Text Type: N, H10
[94842539]
An employee was using the automatic rotator over the weekend when the equipment sparked. Plant operations was called and the employee who responded said to unplug the equipment and call clinical engineering. When the manager arrived to work on the following monday, the equipment had red tape across it, which stated "do not use". The employee was seen in the emergency department over the weekend, following the incident. Per manager, the employee was working with the rotator and a spark arched to her ring. The glove appeared to be burned. The employee stated the glove caught fire, but she was not burned. She then went to the ed. The ed provided a return to work notice, which stated she would be out of work for one day, with follow up to occupational health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7116535 |
| MDR Report Key | 7116535 |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-25 |
| Report Date | 2017-12-01 |
| Date Reported to FDA | 2017-12-01 |
| Date Reported to Mfgr | 2017-12-01 |
| Date Added to Maude | 2017-12-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROTATOR, AUTOMATIC DIGITAL |
| Product Code | GLE |
| Date Received | 2017-12-14 |
| Model Number | 2100A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LW SCIENTIFIC, INC. |
| Manufacturer Address | 865 MARATHON PKWY LAWRENCEVILLE GA 30046 US 30046 |
| Generic Name | ROTATOR, AUTOMATIC DIGITAL |
| Product Code | JQC |
| Date Received | 2017-12-14 |
| Model Number | 2100A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LW SCIENTIFIC, INC. |
| Manufacturer Address | 865 MARATHON PKWY LAWRENCEVILLE GA 30046 US 30046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-14 |