MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-17 for VERSACARE FRAME P3200K000574 manufactured by Hill-rom Batesville.
Report Number | 1824206-2020-00124 |
MDR Report Key | 9845638 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2020-03-17 |
Date of Report | 2020-03-10 |
Date of Event | 2020-03-10 |
Date Mfgr Received | 2020-03-10 |
Device Manufacturer Date | 2016-01-20 |
Date Added to Maude | 2020-03-17 |
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 | LORI DAULTON |
Manufacturer Street | 1069 STATE ROUTE 46 EAST |
Manufacturer City | BATESVILLE IN 47006 |
Manufacturer Country | US |
Manufacturer Postal | 47006 |
Manufacturer Phone | 8129312280 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VERSACARE FRAME |
Generic Name | BED, AC-POWERED ADJUSTABLE HOSPITAL |
Product Code | FNL |
Date Received | 2020-03-17 |
Model Number | P3200K000574 |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HILL-ROM BATESVILLE |
Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-17 |