MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-14 for OUT PATIENT PLUS FLOOR MODEL 010160 0100160 manufactured by Philips Burton.
[18082029]
Philips burton submitted an mdr report for this incident on (b)(6) 2011. However the submission was filed electronically on from 3500. This submission, on the correct form 3500a, is being provided per fda request.
Patient Sequence No: 1, Text Type: N, H10
[18177936]
Philips burton out pt wall mount model detached and fell striking a doctor and causing a concussion and bruising. Medical attention was required (no details were provided). The light was manufactured in (b)(6) 1990's.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018492-2011-00006 |
| MDR Report Key | 2308333 |
| Report Source | 05,06 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-07-13 |
| Date Facility Aware | 2011-07-13 |
| Report Date | 2011-07-13 |
| Date Mfgr Received | 2011-07-13 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 2011-11-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOT KINGHORN |
| Manufacturer Street | 21100 LASSEN STREET |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8187093481 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUT PATIENT PLUS FLOOR MODEL |
| Generic Name | AC POWERED MEDICAL EXAMINATION LIGHT |
| Product Code | FCQ |
| Date Received | 2011-09-14 |
| Model Number | 010160 |
| Catalog Number | 0100160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS BURTON |
| Manufacturer Address | CHATSWORTH CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-14 |