MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-21 for PILL BOX manufactured by Apothecary Products, Llc.
[92646578]
User states while taking their morning pills they flicked the lid open, put the container up to the mouth to swallow the pills in the container and swallowed the lid. The lid, which was swallowed, cut the user internally. The user was hospitalized and had several examinations and tests due to the event, including a colonoscopy. User notes that the box is falling apart and all the lids are breaking off when opened.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0002183416-2017-00002 |
MDR Report Key | 7049238 |
Report Source | CONSUMER |
Date Received | 2017-11-21 |
Date of Report | 2017-11-21 |
Date of Event | 2017-10-30 |
Date Mfgr Received | 2017-10-30 |
Date Added to Maude | 2017-11-21 |
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 | RUSS DAVIES |
Manufacturer Street | 11750 12TH AVE S. |
Manufacturer City | BURNSVILLE MN 55337 |
Manufacturer Country | US |
Manufacturer Postal | 55337 |
Manufacturer Phone | 9528088365 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Generic Name | PILL BOX |
Product Code | NXB |
Date Received | 2017-11-21 |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | APOTHECARY PRODUCTS, LLC |
Manufacturer Address | 11750 12TH AVE S. BURNSVILLE MN 55337 US 55337 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-21 |