MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for HEALTHSMART manufactured by Briggs Medical Service Co. (briggs Healthcare).
[90693704]
Patient Sequence No: 1, Text Type: N, H10
[90693705]
Shards from the bottle (rims for screw top) broke of in the container for one incident. Sheds of red top were in the container for the second incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6986685 |
| MDR Report Key | 6986685 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-23 |
| Report Date | 2017-10-24 |
| Date Reported to FDA | 2017-10-24 |
| Date Reported to Mfgr | 2017-10-24 |
| Date Added to Maude | 2017-10-30 |
| 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 | 0 |
| Brand Name | HEALTHSMART |
| Generic Name | PILL CRUSHER/CUTTER |
| Product Code | OHY |
| Date Received | 2017-10-30 |
| Lot Number | 921-6439-0000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS MEDICAL SERVICE CO. (BRIGGS HEALTHCARE) |
| Manufacturer Address | 1931 NORMAN DR WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |