MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for MEDICHOICE MULTIPURPOSE PILL CRUSHER/SPLITTER PLC1220 manufactured by Medline Industries Inc.
[26424744]
Patient Sequence No: 1, Text Type: N, H10
[26424765]
In attempts to split an uncoated round medication pill into equal halves, the device crushes the pill rendering it unusable as dose cannot safely be determined. Splitting a coated pill is a little better but still results in multiple chunks vs the desired 2 pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5093865 |
| MDR Report Key | 5093865 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-16 |
| Report Date | 2015-09-16 |
| Date Reported to FDA | 2015-09-16 |
| Date Reported to Mfgr | 2015-09-16 |
| Date Added to Maude | 2015-09-22 |
| 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 |
| 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 | MEDICHOICE MULTIPURPOSE PILL CRUSHER/SPLITTER |
| Generic Name | PILL CRUSHER/CUTTER |
| Product Code | OHY |
| Date Received | 2015-09-22 |
| Catalog Number | PLC1220 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-22 |