MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-05-30 for DETECTO UNKNOWN manufactured by Cardinal Scale Mfg..
[3441538]
On (b)(6) 2013 cardinal scales mfg was served legal paperwork stating that a patient of (b)(6) dropped a patient while transporting or moved using a "hoyer" lift manufactured by cardinal/detecto. Cardinal does not have a device specifically called a hoyer lift. Cardinal does manufacture in-bed patient scales under the detecto name. No information specific to the device in question was provided in the paperwork including model number or serial number. If, in actuality, an in-bed patient scale was used for transporting a patient, then it was not used for its intended purpose. Labeling and user instructions for an in-bed patient scale state that it is not to be used for transporting patients and that when lifting a patient for weighing purposes, that the bed must remain under the patient.
Patient Sequence No: 1, Text Type: D, B5
[10841397]
Evaluation of device was not available. Cardinal is using its insurance company and attorney to contact the user facility for information about the scale. Cardinal did not provide any evaluation codes since we do not know anything about the device involved with this incident. At the time of this report no information about the device in question was available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1929045-2013-00002 |
| MDR Report Key | 3162093 |
| Report Source | 00 |
| Date Received | 2013-05-30 |
| Date of Report | 2013-05-29 |
| Date of Event | 2010-09-17 |
| Date Mfgr Received | 2013-05-01 |
| Date Added to Maude | 2013-06-12 |
| 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 ST |
| Manufacturer City | WEBB CITY MO 64870 |
| Manufacturer Country | US |
| Manufacturer Postal | 64870 |
| Manufacturer Phone | 4176734631 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETECTO |
| Generic Name | UNKNOWN |
| Product Code | FRW |
| Date Received | 2013-05-30 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL SCALE MFG. |
| Manufacturer Address | 203 EAST DAUGHERTY ST. WEBB CITY MO 64870 US 64870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-05-30 |