MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-07-22 for ULTRA PILL SPLLITER 70068 manufactured by Compass Health Brands.
[50263626]
Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[50263627]
The end-user sustained an injury on memorial day ((b)(6) 2016) from the ultra pill splitter. As she was removing the pill, the blade guard spring broke and came down on her index finger. Because the cut was so deep and wouldn't stop bleeding, she had to go to the er for sutures, a tetanus shot and antibiotics for two weeks. She indicated that, had the blade not hit part of her finger nail, she would have lost the end of her finger. The pill splitter was used to cut a small pain reliever (round one), and was only used for pain relievers. She had the product for 3 months, and had never put it in water. She indicated that she had never cleaned the product, she only turns the product upside down to get the dust out of the tray. Finally, after 4-5 weeks, the deep cut had healed, but she does not have any feeling in the end of her finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182780-2016-00008 |
| MDR Report Key | 5816768 |
| Report Source | CONSUMER |
| Date Received | 2016-07-22 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-05-30 |
| Date Mfgr Received | 2016-07-05 |
| Date Added to Maude | 2016-07-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAYCEE NICHOLS |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS OH 44130 |
| Manufacturer Country | US |
| Manufacturer Postal | 44130 |
| Manufacturer Phone | 8009471728 |
| Manufacturer G1 | COMPASS HEALTH BRANDS |
| Manufacturer Street | 11 MORRIS DR. SUITE 111 |
| Manufacturer City | DARTMOUTH, NOVA SCOTIA B3B 1M2 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | B3B 1M2 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA PILL SPLLITER |
| Generic Name | PILL SPLITTER |
| Product Code | OHY |
| Date Received | 2016-07-22 |
| Model Number | 70068 |
| Catalog Number | 70068 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPASS HEALTH BRANDS |
| Manufacturer Address | 11 MORRIS DR. SUITE 111 DARTMOUTH, NOVA SCOTIA B3B 1M2 CA B3B 1M2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-22 |