MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-12-04 for DIAGNOST 76 9870-694-12172 manufactured by Philips Systeme Medezin.
[38118]
During a barium exam, the pt was told to reach overhead to hold onto the handles while table was tilted upwards. As the pt was reaching for the handles, his reach went beyond the handles and he grabbed the barium cover of the table. The pt sustained cuts on two fingers allegedly due to the barium cover being bent. The pt's cut fingers required stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1996-00032 |
| MDR Report Key | 54313 |
| Report Source | 06 |
| Date Received | 1996-12-04 |
| Date of Report | 1996-11-14 |
| Date of Event | 1996-11-14 |
| Date Facility Aware | 1996-11-14 |
| Report Date | 1996-11-14 |
| Date Reported to FDA | 1996-12-03 |
| Date Reported to Mfgr | 1996-11-14 |
| Date Mfgr Received | 1996-11-14 |
| Date Added to Maude | 1996-12-11 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 |
| Generic Name | X-RAY TABLE |
| Product Code | IXL |
| Date Received | 1996-12-04 |
| Model Number | 9870-694-12172 |
| Catalog Number | NI |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 54878 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | * HAMBURG GM |
| Baseline Brand Name | DIAGNOST 76 |
| Baseline Generic Name | GENERAL PURPOSE R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED) |
| Baseline Model No | 9870-694-12172 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DIAGNOST 76 FAMILY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K924593 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-04 |