MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-09 for SCOPO 715 9848-500-10001 NA manufactured by Philips Systeme Medezin.
[133808]
Reportedly, a 3 year old pt while moving arms and hands around allegedly hit the cone side of the spot film device carriage and reportedly cut her hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1998-00012 |
| MDR Report Key | 162803 |
| Report Source | 05,06 |
| Date Received | 1998-04-09 |
| Date of Report | 1998-03-12 |
| Date of Event | 1998-03-11 |
| Date Facility Aware | 1998-03-11 |
| Report Date | 1998-03-12 |
| Date Reported to Mfgr | 1998-03-12 |
| Date Mfgr Received | 1998-03-12 |
| Date Added to Maude | 1998-04-17 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOPO 715 |
| Generic Name | SPOT FILM DEVICE |
| Product Code | IXL |
| Date Received | 1998-04-09 |
| Model Number | 9848-500-10001 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 4512-130-32062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 158508 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | SCOPO 715 |
| Baseline Generic Name | SPOT FILM DEVICE |
| Baseline Model No | 9848-500-10001 |
| Baseline Catalog No | NA |
| Baseline ID | 4512-130-32062 |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| 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 | 1998-04-09 |