MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-29 for SKYTRON B1-020-99-1 manufactured by Microtek.
[6831061]
Two light handle covers fell into the sterile field while a patient was present. No injuries were reported. Facility is returning the parts to skytron for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2015-00031 |
| MDR Report Key | 4892370 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-24 |
| Date Facility Aware | 2015-06-25 |
| Report Date | 2015-06-25 |
| Date Reported to FDA | 2015-06-26 |
| Date Reported to Mfgr | 2015-06-26 |
| Date Added to Maude | 2015-07-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5000 36TH ST., S.E. |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal | 49512 |
| Manufacturer G1 | SKYTRON, DIV. THE KMW GROUP, INC. |
| Manufacturer Street | 5000 36TH ST., S.E. |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49512 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | LITE LOK HANDLE COVER |
| Product Code | EBA |
| Date Received | 2015-06-29 |
| Model Number | B1-020-99-1 |
| Lot Number | 140526F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK |
| Manufacturer Address | COLUMBUS MS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-29 |