MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-29 for SAHARA BONE DENSITOMETER * manufactured by Hologic Inc.
[19155115]
Pt had a sahara bone density screening of left heel that reported score of -1. 8 indicating high risk of developing osteoporosis. A second scan of right heel gave a score of -1. 7. Followup dexa scan indicated t score of +. 90 for lumbar spine and -. 1 for left hip. No one has been able to explain why they got such misleading results from the sahara scan. Pt is out of pocket over $400 for the dexa scan since insurance won't cover it because it was necessary at pt's age.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025195 |
| MDR Report Key | 397421 |
| Date Received | 2002-05-29 |
| Date of Report | 2002-05-29 |
| Date of Event | 2002-05-07 |
| Date Added to Maude | 2002-06-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAHARA BONE DENSITOMETER |
| Generic Name | ULTRASOUND BONE DENSITOMETER |
| Product Code | KGI |
| Date Received | 2002-05-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 386475 |
| Manufacturer | HOLOGIC INC |
| Manufacturer Address | 35 CROSBY DR BEDFORD MA 01730 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-29 |