MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for SUBDERMAL NEEDLE ELECTRODE RLSND121-2.5 manufactured by Rhythmlink International Llc.
[131040270]
Hospital reports that a needle has broken off in a patient. The report was submitted to rhythmlink quality through rhythmlink sales dept by phone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082190 |
| MDR Report Key | 8174684 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-05 |
| Date Added to Maude | 2018-12-18 |
| 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 | UNKNOWN |
| 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 | SUBDERMAL NEEDLE ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2018-12-17 |
| Model Number | RLSND121-2.5 |
| Catalog Number | RLSND121-2.5 |
| Lot Number | P000009937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RHYTHMLINK INTERNATIONAL LLC |
| Manufacturer Address | COLUMBIA SC 29209 US 29209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-17 |