MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-19 for PILL CRUSHER 921-6439-0000 10/10 640-6439-0000 manufactured by Briggs Medical Service Company.
[5876227]
During the twisting/crushing of the pill (norvasc) the bottom of crusher broke contaminating the medication. The pill and a portion of the upper level of the pill crusher fell into bottom portion of the pill compartment. ======================manufacturer response for pill crusher, (brand not provided) (per site reporter). ======================i talked to customer service (b)(4). Sent her an email stating the details of the incident and asked to start the process for returning the pill crusher for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4790488 |
| MDR Report Key | 4790488 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-05-19 |
| Date of Event | 2015-05-15 |
| Report Date | 2015-05-19 |
| Date Reported to FDA | 2015-05-19 |
| Date Reported to Mfgr | 2015-05-22 |
| Date Added to Maude | 2015-05-22 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILL CRUSHER |
| Generic Name | PILL CRUSHER/CUTTER |
| Product Code | KME |
| Date Received | 2015-05-19 |
| Model Number | 921-6439-0000 10/10 |
| Catalog Number | 640-6439-0000 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 3 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS MEDICAL SERVICE COMPANY |
| Manufacturer Address | 7887 UNIVERSITY BLVD. DES MOINES IA 50306 US 50306 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-19 |