MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for NEUROLINE INOJECTNEUROLOGY NEEDLE ELECTRODES 74425-30/10 manufactured by Ambu A/s.
[142626705]
Botox injections using the neurology needle electrode on patient. 4-5 done and on the next one needle broke off in the thigh. A couple of days later, the patient taken to operating room and unable to retrieve the needle from the thigh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8535309 |
| MDR Report Key | 8535309 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-04-05 |
| Report Date | 2019-04-08 |
| Date Reported to FDA | 2019-04-08 |
| Date Reported to Mfgr | 2019-04-22 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| 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 | NEUROLINE INOJECTNEUROLOGY NEEDLE ELECTRODES |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2019-04-22 |
| Model Number | 74425-30/10 |
| Catalog Number | 74425-30/10 |
| Lot Number | 1000098146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |