MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-03 for THEME SERIES INFANT SCALE/TABLE 7830 manufactured by Clinton Industries Inc.
[18613524]
The screws that attached the fall protection plexi-glass end on an infant scale are stripping out. A sibling of a pt in the pediatrics clinic was seen with the screws in his hand. Potential choking and fall hazard. Medical maintenance inspected all the infant scales in our facility out of the 11 scales medical maintenance identified and repaired on the spot 10 scales. Dates of use: (b)(6) 2008 to present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019339 |
| MDR Report Key | 1985386 |
| Date Received | 2011-02-03 |
| Date of Report | 2010-12-23 |
| Date of Event | 2010-12-21 |
| Date Added to Maude | 2011-02-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THEME SERIES INFANT SCALE/TABLE |
| Generic Name | INFANT SCALE |
| Product Code | FRW |
| Date Received | 2011-02-03 |
| Model Number | 7830 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINTON INDUSTRIES INC |
| Manufacturer Address | 1140 EDISON ST YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-03 |