MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for MICRO BALL PROBES AND HOOKS manufactured by Life Instrument Corporation.
[158738130]
The ball of a 3 mm micro ball probe got dislodged during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5089742 |
| MDR Report Key | 9008513 |
| Date Received | 2019-09-11 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-09-03 |
| Date Added to Maude | 2019-09-12 |
| 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 |
| 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 | 0 |
| Brand Name | MICRO BALL PROBES AND HOOKS |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-09-11 |
| Lot Number | 847-0703-0 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE INSTRUMENT CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-11 |