MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-07-09 for FUJI IP CASSETTE 3A 503147BWA manufactured by Fuji Photo Film Co., Ltd..
[125559]
An er tech reported that a <2mm metal burr became lodged in her index finger while handling a radiographic cassette. A physician used a scalpel to create an opening to locate and retrieve the metal fragment. The tech was treated with approx 2-3 suture stitches to close the laceration with no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2443168-1999-00001 |
| MDR Report Key | 231482 |
| Report Source | 05 |
| Date Received | 1999-07-09 |
| Date of Report | 1999-07-09 |
| Date of Event | 1999-06-01 |
| Date Mfgr Received | 1999-06-09 |
| Date Added to Maude | 1999-07-14 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJI IP CASSETTE 3A |
| Generic Name | RADIOGRAPHIC CASSETTE |
| Product Code | IXA |
| Date Received | 1999-07-09 |
| Returned To Mfg | 1999-06-10 |
| Model Number | NA |
| Catalog Number | 503147BWA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 224379 |
| Manufacturer | FUJI PHOTO FILM CO., LTD. |
| Manufacturer Address | 26-30 NISHIAZABU 2-CHOME MINATO-KU, TOKYO * 106-8620 |
| Baseline Brand Name | FUJI IP CASSETTE 3A |
| Baseline Generic Name | RADIOGRAPHIC CASSETTE |
| Baseline Catalog No | 503147BWA |
| Baseline ID | COMPUTED RADIOG |
| Baseline Device Family | COMPUTED RADIOGRAPHY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K944046 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-09 |