MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-04 for MIDMARK 529-060-00 manufactured by Midmark Corp..
[21340016]
The clinician user grabbed the handle to move the light when the bulb cracked. A piece of the bulb landed on the clinician's gown. No medical attention required.
Patient Sequence No: 1, Text Type: D, B5
[21705719]
Voltage testing performed as expected. No performance issues were identified. The unit was not returned to midmark for assessment. This product is no longer manufactured by midmark. There is no history of similar event. Unable to confirm cause of the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2015-00004 |
| MDR Report Key | 4828022 |
| Report Source | 06 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-03 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-05-04 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANE CARROL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268604 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | SURGICAL LIGHT |
| Product Code | EAZ |
| Date Received | 2015-06-04 |
| Model Number | 529-060-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |