MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-12-23 for DETECTO 6868 manufactured by Cardinal Scale Mfg. Co..
[5263184]
On (b)(6) 2014 cardinal scale mfg was made aware of litigation for an alleged incident that involved the use of a detecto scale. In this litigation it is claimed that a healthcare professional commanded the pt to stand on scale. At this time the pt was struck by a fold down seat from the scale. Pt is claiming that this caused further damage to knee that had been surgically reconstructed days earlier.
Patient Sequence No: 1, Text Type: D, B5
[12725837]
Cardinal is in process of making contact with the facility to evaluate the device in question. Will submit follow up report once eval is completed. The model number and serial number of scale in this report is based on description of scale in paperwork and records of scales sold to this location.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1929045-2014-00002 |
| MDR Report Key | 4372875 |
| Report Source | 99 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-22 |
| Date of Event | 2011-12-21 |
| Device Manufacturer Date | 2010-12-08 |
| Date Added to Maude | 2015-01-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 203 EAST DAUGHERTY |
| Manufacturer City | WEBB CITY MO 64870 |
| Manufacturer Country | US |
| Manufacturer Postal | 64870 |
| Manufacturer G1 | CARDINAL SCALE MFG. CO. |
| Manufacturer Street | 203 EAST DAUGHERTY |
| Manufacturer City | WEBB CITY MO 64870 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETECTO |
| Generic Name | BARIATRIC SCALE DIGITAL 1000 LB X .2 LB |
| Product Code | FRW |
| Date Received | 2014-12-23 |
| Model Number | 6868 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL SCALE MFG. CO. |
| Manufacturer Address | 203 EAST DAUGHERTY ST. WEBB CITY MO 64870 US 64870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-23 |