MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for BOJECT 9013S0422 9013SO422 manufactured by Natus Manufacturing Limited.
[130040869]
During procedure to inject botulinum toxin in the right medial hamstring the needle broke requiring surgical intervention to retrieve the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8154542 |
| MDR Report Key | 8154542 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-12-04 |
| Report Date | 2018-12-06 |
| Date Reported to FDA | 2018-12-06 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2018-12-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BOJECT |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2018-12-12 |
| Model Number | 9013S0422 |
| Catalog Number | 9013SO422 |
| Lot Number | 1803LL04 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | 5955 PACIFIC CENTER BOULEVARD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-12 |