MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-22 for CODMAN 23-1042 SIZE 00 manufactured by Johnson & Johnson.
[40069]
During removal of metastatic spinal tumor, with primary diagnosis of esophageal ca, a small curette head broke off and lodged in the pt tissue. This piece was unable to be found so the wound was closed, since it was felt continuing to search would be more risky than leaving the particle in the pt. Last op xray identified the particle in the space between the spinal column and the lung pleura.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 63715 |
| MDR Report Key | 63715 |
| Date Received | 1997-01-22 |
| Date of Report | 1997-01-02 |
| Date of Event | 1996-12-23 |
| Date Facility Aware | 1996-12-24 |
| Report Date | 1997-01-01 |
| Date Added to Maude | 1997-01-23 |
| 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 | CODMAN |
| Generic Name | BONE CURETTE |
| Product Code | HTF |
| Date Received | 1997-01-22 |
| Model Number | 23-1042 |
| Catalog Number | SIZE 00 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 63875 |
| Manufacturer | JOHNSON & JOHNSON |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Baseline Brand Name | SPINAL CURETTE |
| Baseline Generic Name | CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 23-1042 |
| Baseline ID | * |
| Baseline Device Family | CURETTES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-22 |