MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-05 for FUJI IP CASSETTE 3 * R503147 manufactured by Fuji Photo Film Co., Ltd..
[19079688]
Two radiological technicians each received one carbon fiber splinter in their index finger while handling radiographic cassettes. The splinters were removed from the fingers of both technicians. One technician was treated with approximately 2-3 suture stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2443168-1998-00002 |
| MDR Report Key | 171105 |
| Report Source | 05 |
| Date Received | 1998-06-05 |
| Date of Report | 1998-06-05 |
| Date of Event | 1998-05-08 |
| Date Mfgr Received | 1998-05-08 |
| Date Added to Maude | 1998-06-09 |
| 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 3 |
| Generic Name | RADIOGRAPHIC CASSETTE |
| Product Code | IXA |
| Date Received | 1998-06-05 |
| Returned To Mfg | 1998-05-11 |
| Model Number | * |
| Catalog Number | R503147 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 166426 |
| Manufacturer | FUJI PHOTO FILM CO., LTD. |
| Manufacturer Address | 26-30 NISHIAZABU 2-CHOME MINATO-KU, TOKYO JA 106-8620 |
| Baseline Brand Name | FUJI IP CASSETTE 3 |
| Baseline Generic Name | RADIOGRAPHIC CASSETTE |
| Baseline Model No | * |
| Baseline Catalog No | R503147 |
| Baseline ID | COMPUTED RADIOG |
| Baseline Device Family | COMPUTED RADIOGRAPHY |
| Baseline Shelf Life Contained | N |
| 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 | 1998-06-05 |