MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-08-16 for SINGLE HEAD GENESYS 2129-3011A NA manufactured by Adac Laboratories.
[17034534]
As part of a bone scan, static views of the pt's feet were taken. The technologist had performed the study had lowered the camera down over the feet of the pt and had unintentionally touched the pt's feet with the collimator. The emergency stop lit and indicated a collision. No pt injury was reported at the time, but the pt now is complaining of permanent injury to his feet, and is attributing this injury to the bone scanning procedure he underwent in january.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-1999-00131 |
| MDR Report Key | 236463 |
| Report Source | 07 |
| Date Received | 1999-08-16 |
| Date of Report | 1999-07-16 |
| Date of Event | 1999-01-14 |
| Date Mfgr Received | 1999-07-16 |
| Device Manufacturer Date | 1995-05-01 |
| Date Added to Maude | 1999-08-23 |
| 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 | 0 |
| Manufacturer Contact | JANICE BROWN, DIRECTOR OF RA |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 950357443 |
| Manufacturer Country | US |
| Manufacturer Postal | 950357443 |
| Manufacturer Phone | 4084683766 |
| Manufacturer G1 | ADAC LABORATORIES |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 95035744 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 7443 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE HEAD GENESYS |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IXY |
| Date Received | 1999-08-16 |
| Model Number | 2129-3011A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 229160 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DR. MILPITAS CA 950357443 US |
| Baseline Brand Name | GENESYS |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2129-3011A |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NUCLEAR MEDICINE EQUIPMENT |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900689 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-16 |