MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-01 for QDR BONE DENSITOMETER QDR 4500 SL manufactured by Hologic, Inc..
[896289]
Customer e-mail hologic and reported the following: one of their pt reported that she stared at a positioning laser light for approx 1 1/2 mins, and only then she noticed the warning sign that said not to stare into the light. The pt said that her eyes have been hurting/bothering her since that time, so she went to the eye doctor. Doctor told her that she had bleeding behind her eyes and that it could have been caused by laser light.
Patient Sequence No: 1, Text Type: D, B5
[8016605]
The design spec for the laser was reviewed - it was determined that the laser never moves over pt's head. It is a positioning laser and shuts off automatically after 30 seconds. This was confirmed by field service engineer. The laser is class ii, but recent testing by an independent lab indicated that the laser rather than class ii falls into category i laser, which is the safest laser, and there should be no possibility of the reported injury. Based on all available info and the testing of the device, our conclusion is that the device performs in accordance with the spec and we cannot confirm that the injury reported by the pt was related to our device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221300-2008-00005 |
| MDR Report Key | 1073970 |
| Report Source | 05,06 |
| Date Received | 2008-07-01 |
| Date of Report | 2008-07-01 |
| Date of Event | 2008-05-23 |
| Date Mfgr Received | 2008-06-05 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2009-05-04 |
| 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 | LIDA REED, DIR |
| Manufacturer Street | 35 CROSBY DR. |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7819997589 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QDR BONE DENSITOMETER |
| Generic Name | BONE DENSITOMETER |
| Product Code | KGI |
| Date Received | 2008-07-01 |
| Model Number | QDR 4500 SL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | BEDFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-01 |