FDA Adverse Event
Injury
Summary report: N
DETECTO
MDR report key: 4372875
·
Received December 23, 2014
Report
- Report Number
- 1929045-2014-00002
- Event Type
- Injury
- Date Received
- December 23, 2014
- Date of Event
- December 21, 2011
- Report Date
- December 22, 2014
- Manufacturer
- CARDINAL SCALE MFG. CO.
- Product Code
- FRW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849323 | DETECTO | BARIATRIC SCALE DIGITAL 1000 LB X .2 LB | FRW | CARDINAL SCALE MFG. CO. | 6868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |