MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for BIOSTIM SD KBSD manufactured by Biomedical Life Systems Inc..
| Report Number | 2024292-2019-00001 |
| MDR Report Key | 9836506 |
| Report Source | CONSUMER |
| Date Received | 2020-03-16 |
| Date of Report | 2019-08-20 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2020-03-16 |
| 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 | MRS. KATHERINE KLEM |
| Manufacturer Street | 1954 KELLOGG AVE |
| Manufacturer City | CARLSBAD, |
| Manufacturer Country | US |
| Manufacturer Phone | 5790801 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTIM SD |
| Generic Name | BIOSTIM SD TENS UNIT |
| Product Code | GZJ |
| Date Received | 2020-03-16 |
| Model Number | KBSD |
| Catalog Number | KBSD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMEDICAL LIFE SYSTEMS INC. |
| Manufacturer Address | 1954 KELLOGG AVE CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |