MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-14 for SECA 644 manufactured by Seca Corp..
[28152643]
Patient Sequence No: 1, Text Type: N, H10
[28152644]
The scale is very sensitive to being balance so it has a level built in so the user or service person knows if it is balanced. The level is located on the back of the scale partially under the base so if this scale is near a wall (which most scales are) it is impossible to see the level.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5147785 |
| MDR Report Key | 5147785 |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-29 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | BIOMEDICAL ENGINEER |
| 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 | 3 |
| Brand Name | SECA |
| Generic Name | SCALE |
| Product Code | FRW |
| Date Received | 2015-10-14 |
| Model Number | 644 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECA CORP. |
| Manufacturer Address | 13601 BENSON AVE CHINO, CA 91710 US 91710 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-14 |