MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for CAPIO SLIM M0068318170 manufactured by Boston Scientific.
[99902282]
Device malfunction, small piece fell off device, location at this time. Not in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075176 |
| MDR Report Key | 7263282 |
| Date Received | 2018-02-09 |
| Date of Event | 2018-02-02 |
| Date Added to Maude | 2018-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | CAPIO SLIM |
| Generic Name | CAPIO SLIUM |
| Product Code | PWI |
| Date Received | 2018-02-09 |
| Model Number | M0068318170 |
| Lot Number | 0000054926 |
| Device Expiration Date | 2018-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-09 |