MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-07-24 for AUTOMATIC CASSETTE LOADER (ACL) 249112SR manufactured by Liebel-flarsheim Co..
[20244718]
While doing a posterior anterior chest film, a pt somehow caught her thumb in the bucky mechanism on the chest unit. Apparently the pt needed to wrap her arms around the unit to support herself. As the cassette automatically ejected. Pt's thumb was caught by the cassette. Pt required sutures in the emergency room by the physician on duty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-1998-00019 |
| MDR Report Key | 178986 |
| Report Source | 05,06 |
| Date Received | 1998-07-24 |
| Date of Report | 1998-07-24 |
| Date of Event | 1998-06-03 |
| Date Facility Aware | 1998-06-03 |
| Report Date | 1998-07-24 |
| Date Mfgr Received | 1998-06-25 |
| Date Added to Maude | 1998-07-29 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOMATIC CASSETTE LOADER (ACL) |
| Generic Name | SUCKY/SIZE-SENSING CASSETTE TRAY |
| Product Code | IXA |
| Date Received | 1998-07-24 |
| Model Number | NA |
| Catalog Number | 249112SR |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 37 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174036 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45215 US |
| Baseline Brand Name | AUTOMATIC CASSETTE LOADER (ACL) |
| Baseline Generic Name | SUCKY/SIZE-SENSING CASSETTE TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 249112SR |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-07-24 |