MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-02 for PHILLIPS DEAGAST U/M manufactured by Phillips Medical Systems.
[17480510]
While doing mammogram on pt the spot compression device was stuck on pt while in full compression. Rptr tried to unlock compression device and was successful after about 30 secs. The pt said, "that hurt". Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-94. Service provided by: independent factory trained/authorized service organization. Service records available. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8752 |
| MDR Report Key | 8752 |
| Date Received | 1994-08-02 |
| Date of Report | 1994-07-29 |
| Date of Event | 1994-07-20 |
| Date Facility Aware | 1994-07-20 |
| Report Date | 1994-07-29 |
| Date Reported to FDA | 1994-07-29 |
| Date Reported to Mfgr | 1994-07-20 |
| Date Added to Maude | 1994-10-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILLIPS DEAGAST U/M |
| Generic Name | DEAGAST U/M |
| Product Code | IXL |
| Date Received | 1994-08-02 |
| ID Number | 987140036022 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8413 |
| Manufacturer | PHILLIPS MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-02 |