MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-06 for PILL CRUSHER PC1226 manufactured by Health Enterprises.
[4507652]
Pill crusher used to crush protonix. Clear plastic inside portion broke during crushing, resulting in shards of plastic being mixed with protonix. Medication was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036537 |
| MDR Report Key | 3870189 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-06-05 |
| Date of Event | 2014-04-01 |
| Date Added to Maude | 2014-06-16 |
| 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 | 3 |
| 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 | PILL CRUSHER |
| Generic Name | PILL CRUSHER |
| Product Code | OHY |
| Date Received | 2014-06-06 |
| Model Number | PC1226 |
| Lot Number | PC1226 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTH ENTERPRISES |
| Manufacturer Address | NORTH ATTLEBORO 02760 02760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-06 |