MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-04 for RLSND131-2.5 manufactured by Rhythmlink International Llc.
| Report Number | 1067162-2019-00001 |
| MDR Report Key | 8961064 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-09-04 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-07-24 |
| Date Mfgr Received | 2019-07-24 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. GERALD KEISLER |
| Manufacturer Street | 1140 1ST STREET SOUTH |
| Manufacturer City | COLUMBIA SC 29209 |
| Manufacturer Country | US |
| Manufacturer Postal | 29209 |
| Manufacturer Phone | 8032521222 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Street | SAME AS ABOVE |
| Manufacturer City | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RLSND131-2.5 |
| Generic Name | SUBDERMAL NEEDLE |
| Product Code | GXZ |
| Date Received | 2019-09-04 |
| Model Number | RLSND131-2.5 |
| Catalog Number | RLSND131-2.5 |
| Lot Number | P000010966 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RHYTHMLINK INTERNATIONAL LLC |
| Manufacturer Address | 1140 1ST STREET SOUTH COLUMBIA SC 29209 US 29209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-04 |