MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-18 for 1304 OPEN BACK HALO RING-MEDIUM manufactured by Depuy Ace Medical Co..
[16786833]
Burning sensation at pin insertion point during magnetic resonance imaging. Brand new machine with very high powered magnets. Ge signa horizon, 1. 5 tesia. The pt, a 40 yr old male, was wearing an open back halo ring with a mark iv vest had burning sensations at the pin sites during magnetic resonance imaging. The machine is new with very high powered magnets. It was a ge signa horizon that runs at 1. 5 tesia. The tech ran the pt for 3 very short (15 seconds each) scans. The pt was partially sedated but by third scan was semi-roused out of sedation due to the heating sensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020311-1998-00007 |
| MDR Report Key | 173657 |
| Report Source | 05 |
| Date Received | 1998-06-18 |
| Date of Report | 1998-05-19 |
| Date of Event | 1998-05-07 |
| Date Facility Aware | 1998-05-07 |
| Report Date | 1998-05-19 |
| Date Mfgr Received | 1998-05-19 |
| Date Added to Maude | 1998-06-25 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1304 OPEN BACK HALO RING-MEDIUM |
| Generic Name | CERVICAL TRACTION |
| Product Code | KQZ |
| Date Received | 1998-06-18 |
| Model Number | NA |
| Catalog Number | 1304 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 168847 |
| Manufacturer | DEPUY ACE MEDICAL CO. |
| Manufacturer Address | 2260 EAST EL SEGUNDO BLVD. EL SEGUNDO CA 90245 US |
| Baseline Brand Name | 1304 OPEN BACK HALO RING-MEDIUM |
| Baseline Generic Name | HALO RING |
| Baseline Model No | NA |
| Baseline Catalog No | 1304 |
| Baseline ID | * |
| Baseline Device Family | CERVICAL TRACTION |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K914858 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-06-18 |