MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-10-17 for NI manufactured by Depuy Ace Medical Co..
[21045560]
During mri, patient felt burning sensation at pin insertion points of halo system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020311-1997-00047 |
| MDR Report Key | 127333 |
| Report Source | 07 |
| Date Received | 1997-10-17 |
| Date of Report | 1997-10-16 |
| Date Facility Aware | 1997-09-16 |
| Report Date | 1997-10-16 |
| Date Mfgr Received | 1997-09-16 |
| Date Added to Maude | 1997-10-23 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | NI |
| Product Code | KQZ |
| Date Received | 1997-10-17 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 124590 |
| Manufacturer | DEPUY ACE MEDICAL CO. |
| Manufacturer Address | 2260 EAST EL SEGUNDO BLVD. EL SEGUNDO CA 90245 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-17 |