MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-28 for 7-DAY MEDIPLANNER 70069B manufactured by Compass Health Brands.
[51743231]
The customer called to report that he was dumping his pills out of his container, and a plastic piece came out of the medicine planner, in which he almost took with his other pills. When you open the purple row (of the reported defective planner), it looks like the plastic cutting press used during manufacturing of the device may need to be sharpened due to the excess plastic piece leftover (in which customer is reporting on). The customer also suggested that the air pressure that would blow excess plastic pieces way may need to be adjusted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182780-2016-00009 |
| MDR Report Key | 5831284 |
| Date Received | 2016-07-28 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-07-08 |
| Date Mfgr Received | 2016-07-08 |
| Date Added to Maude | 2016-07-28 |
| 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 | 0 |
| Brand Name | 7-DAY MEDIPLANNER |
| Generic Name | MEDICINE PLANNER |
| Product Code | NXQ |
| Date Received | 2016-07-28 |
| Returned To Mfg | 2016-07-21 |
| Model Number | 70069B |
| Catalog Number | 70069B |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2016-07-28 |