MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-03-30 for DIAGNOST 76 PLUS 9848-500-16202 NA manufactured by Philips Medezin Systeme.
[16614735]
Reportedly, the patient was laying prone on the table with toes hanging off the tabletop to accommodate the patient's height. As the tabletop was moved towards the foot end, the patient's toes became pinched between tabletop and table resulting in a fracture of one toe and additional trauma to other toes. The patient received medical treatment in er for the fractured toe, and the toenails on two other toes had to be drilled out to relieve pressure due to clotting in both toes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2001-00004 |
| MDR Report Key | 323949 |
| Report Source | 05,06 |
| Date Received | 2001-03-30 |
| Date of Report | 2001-02-28 |
| Date of Event | 2001-02-23 |
| Date Facility Aware | 2001-02-23 |
| Report Date | 2001-02-28 |
| Date Reported to Mfgr | 2001-02-28 |
| Date Mfgr Received | 2001-02-28 |
| Date Added to Maude | 2001-04-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRANK GIANELLI |
| Manufacturer Street | 710 BRIDGEPORT AVE PO BOX 860 |
| Manufacturer City | SHELTON CT 064840917 |
| Manufacturer Country | US |
| Manufacturer Postal | 064840917 |
| Manufacturer Phone | 2039267729 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 PLUS |
| Generic Name | GENERAL PURPOSE R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED). |
| Product Code | IXL |
| Date Received | 2001-03-30 |
| Model Number | 9848-500-16202 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 313419 |
| Manufacturer | PHILIPS MEDEZIN SYSTEME |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | DIAGNOST 76 PLUS |
| Baseline Generic Name | GENERAL PURPOSE R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED) |
| Baseline Model No | 9848-500-16202 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DIAGNOST 76 FAMILY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K924593 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-30 |