MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-06-02 for ULTRA-DRIVE PLUG PULLER 423868 manufactured by *.
| Report Number | 1825034-1997-00040 |
| MDR Report Key | 96034 |
| Report Source | 07 |
| Date Received | 1997-06-02 |
| Date of Event | 1997-05-05 |
| Date Mfgr Received | 1997-05-02 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1997-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE PLUG PULLER |
| Generic Name | CEMENT REMOVAL SYSTEM |
| Product Code | LZV |
| Date Received | 1997-06-02 |
| Model Number | NA |
| Catalog Number | 423868 |
| Lot Number | 162580 |
| ID Number | NA |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 94818 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-02 |