MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-01 for ADAC DUAL HEAD DUAL HEAD GENESYS * manufactured by Adac Labs Corporation (phone# 1800 Adac 123).
[213186]
Pt underwent bone scan performed on adac dual head genesys gamma camera. The pt's hair was very long, and wrapped around the turn screws several times before it was noticed. The camera was immediately turned off, attempts made to free hair, required some cutting of hair. Pt unharmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 375495 |
| MDR Report Key | 375495 |
| Date Received | 2002-02-01 |
| Date of Report | 2001-12-31 |
| Date of Event | 2001-12-15 |
| Date Facility Aware | 2001-12-15 |
| Report Date | 2001-12-31 |
| Date Added to Maude | 2002-02-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADAC DUAL HEAD |
| Generic Name | DUAL HEAD GENESYS |
| Product Code | IXY |
| Date Received | 2002-02-01 |
| Model Number | DUAL HEAD GENESYS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 364601 |
| Manufacturer | ADAC LABS CORPORATION (PHONE# 1800 ADAC 123) |
| Manufacturer Address | 540 ALDER DR MILPITAS CA 95035 US |
| Baseline Brand Name | GENESYS |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2144-3000B |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NUCLEAR MEDICINE EQUIPMENT |
| 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 | 2002-02-01 |