MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-20 for FASCIABLASTER 89-IOS AT 21 manufactured by Adb Interests, Llc.
Report Number | MW5089211 |
MDR Report Key | 8915554 |
Date Received | 2019-08-20 |
Date of Report | 2019-08-17 |
Date of Event | 2018-02-11 |
Date Added to Maude | 2019-08-21 |
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 | PATIENT |
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 | FASCIABLASTER |
Generic Name | MASSAGER, THERAPEUTIC, MANUAL |
Product Code | LYG |
Date Received | 2019-08-20 |
Model Number | 89-IOS AT 21 |
Lot Number | CFR 8905350 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ADB INTERESTS, LLC |
Brand Name | MINI BLASTER |
Generic Name | MASSAGER, THERAPEUTIC, MANUAL |
Product Code | LYG |
Date Received | 2019-08-20 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | ADB INTERESTS, LLC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2019-08-20 |