MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-02 for OUTPATIENT II SINGLE CEILING OPII216SC manufactured by Philips Burton.
[3503924]
On (b)(6) 2013, philips burton received a complaint stating that one of our single ceiling lights had detached. No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009542956-2013-00007 |
| MDR Report Key | 3108955 |
| Report Source | 05 |
| Date Received | 2013-05-02 |
| Date of Report | 2013-04-17 |
| Date Mfgr Received | 2013-04-17 |
| Device Manufacturer Date | 2010-11-17 |
| Date Added to Maude | 2013-07-10 |
| 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 | 3 |
| Manufacturer Contact | TOM MATIONG |
| Manufacturer Street | 11500 MELROSE AVE |
| Manufacturer City | FRANKLIN PARK IL 60131 |
| Manufacturer Country | US |
| Manufacturer Postal | 60131 |
| Manufacturer Phone | 8472888948 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTPATIENT II SINGLE CEILING |
| Generic Name | OUTPATIENT II SINGLE SEILING |
| Product Code | FQP |
| Date Received | 2013-05-02 |
| Model Number | OPII216SC |
| Catalog Number | OPII216SC |
| ID Number | NA |
| Device Expiration Date | 2010-11-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS BURTON |
| Manufacturer Address | 11500 MELROSE AVE FRANKLIN PARK IL 60131 US 60131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-02 |