MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for ULTRASOUND PROBE M0068407170 manufactured by Boston Scientific Corporation.
[115556425]
The ultrasound probe busted. It was removed from the field and a new one was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7734911 |
| MDR Report Key | 7734911 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-07-18 |
| Report Date | 2018-07-20 |
| Date Reported to FDA | 2018-07-20 |
| Date Reported to Mfgr | 2018-07-31 |
| Date Added to Maude | 2018-07-31 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-07-27 |
| Model Number | M0068407170 |
| Catalog Number | M0068407170 |
| Lot Number | 2240371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH , MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |