MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for SECA 402 manufactured by Seca Corp.
[101766194]
Patient Sequence No: 1, Text Type: N, H10
[101766195]
Both wheels on the end of the cart fell off when the cart was moved slightly during the weighing process, the parents caught the infant as it was sliding off the scale which was tilted. Manufacturer response for wheeled cart, custom made for the scale, seca (per site reporter) manufacturer was concerned and requested to be kept in the loop on the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7319859 |
| MDR Report Key | 7319859 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-03-05 |
| Report Date | 2018-03-06 |
| Date Reported to FDA | 2018-03-06 |
| Date Reported to Mfgr | 2018-03-06 |
| Date Added to Maude | 2018-03-07 |
| 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 | RISK MANAGER |
| 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 | WHEELED CART |
| Product Code | FRW |
| Date Received | 2018-03-07 |
| Model Number | 402 |
| Catalog Number | 402 |
| Lot Number | NA |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 3 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 | 2018-03-07 |