MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-14 for ECOLAB RWJUH-NB-04D manufactured by Microtek Medical Inc..
[179704676]
It was reported that a patent fell out of the arm board cover and fractured their right radius as a result of the fall. Medical intervention was required and the arm was placed in a cast to prevent permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043582-2020-00001 |
| MDR Report Key | 9714313 |
| Report Source | CONSUMER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-14 |
| 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. STEVEN DELINE |
| Manufacturer Street | 602 LEHMBERG ROAD |
| Manufacturer City | COLUMBUS, MS |
| Manufacturer Country | US |
| Manufacturer Phone | 2503744 |
| Manufacturer G1 | MICROTEK MEDICAL INC. |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECOLAB |
| Generic Name | CLEANOP INFECTION CONTROL SYSTEM |
| Product Code | KME |
| Date Received | 2020-02-14 |
| Model Number | RWJUH-NB-04D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL INC. |
| Manufacturer Address | 602 LEHMBERG ROAD COLUMBUS, MS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-14 |