MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-08-07 for DRILL GUIDE, 3.6MM DIA-COMPRSN 3861-3-075 manufactured by Howmedica Inc..
[21585720]
While stocking instrument set at the agency, the sales representative noticed that the package was labeled as 3861-3-075, but actually contained product with catalog number 3861-3-060. This event did not occur during a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610622-1998-00123 |
| MDR Report Key | 181692 |
| Report Source | 07 |
| Date Received | 1998-08-07 |
| Date of Report | 1998-08-06 |
| Date Mfgr Received | 1998-07-20 |
| Date Added to Maude | 1998-08-12 |
| 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 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL GUIDE, 3.6MM DIA-COMPRSN |
| Generic Name | INSTRUMENT |
| Product Code | HXY |
| Date Received | 1998-08-07 |
| Returned To Mfg | 1998-07-20 |
| Model Number | NA |
| Catalog Number | 3861-3-075 |
| Lot Number | K358284 |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 176664 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VERTERANS BLVD RUTHERFORD NJ 07070 US |
| Baseline Brand Name | DRILL GUIDE, 3.6MM DIA-COMPRSN |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 3861-3-075 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-08-07 |