MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for CHALGREN 242-637-24TP-1 manufactured by Chalgren Enterprises.
[107724386]
Patient Sequence No: 1, Text Type: N, H10
[107724387]
Patient was receiving botox injections for spasticity and the needle broke off inside his muscle. Acute care surgery was called to identify the needle via ultrasound and extracted the needle. No retained fragments were identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7498292 |
| MDR Report Key | 7498292 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-02 |
| Date of Event | 2018-05-01 |
| Report Date | 2018-05-02 |
| Date Reported to FDA | 2018-05-02 |
| Date Reported to Mfgr | 2018-05-02 |
| Date Added to Maude | 2018-05-09 |
| 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 | CHALGREN |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2018-05-09 |
| Model Number | 242-637-24TP-1 |
| Catalog Number | 242-637-24TP-1 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHALGREN ENTERPRISES |
| Manufacturer Address | 380 TOMKINS COURT GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-09 |