MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-28 for MATURE MART PILL SPLITTER MMRT 1083 manufactured by Duro-med Industries, Inc..
[170940]
A pill splitter is used to cut tablets in half for accuracy. However, according to rptr, the pill splitter from mature mart needs to be recalled because the cutting blade is misaligned and is giving an inaccurate split of tablets. This may cause serious consequences. The mfr was contacted and the problem was explained. The representative replied "so what do you want me to do? ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002745 |
| MDR Report Key | 274835 |
| Date Received | 2000-03-28 |
| Date of Report | 2000-03-21 |
| Date of Event | 2000-02-01 |
| Date Added to Maude | 2000-04-26 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATURE MART PILL SPLITTER |
| Generic Name | PILL SPLITTER |
| Product Code | OHY |
| Date Received | 2000-03-28 |
| Model Number | NA |
| Catalog Number | MMRT 1083 |
| Lot Number | NI |
| ID Number | NDC 65438-9010-83 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 266018 |
| Manufacturer | DURO-MED INDUSTRIES, INC. |
| Manufacturer Address | P.O. BOX 685 HACKENSACK NJ 07602 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-28 |