MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-17 for KROGER SILICONE EAR PLUG K10-67 manufactured by Apothecary Products, Llc.
[124062500]
Apothecary products was acquired in february 2014 following which a new management team was established. This included a new regulatory and quality systems team. As part of this transition a regulatory and quality system compliance assessment was conducted, which included a three-year retrospective review of complaints from 1 january 2014 to 31 may 2018 to ensure that reported events that meet the reporting requirements of 21 cfr part 803 medical device reporting (mdr) regulation were notified to the fda. During this review, we identified 5 complaints that we believe meet the reporting criteria which were not reported to the fda and are being reported to the fda at this time. New procedures have been implemented to ensure that events that meet the reporting criteria requirements of 21 cfr part 803 are reported to the fda in accordance with regulatory requirements.
Patient Sequence No: 1, Text Type: N, H10
[124062501]
User stated that while using the silicone ear plug in the shower, it "came apart" in his ear. His wife attempted to remove the silicone ear plug with a tweezer. User went to the doctor to have the silicone ear plug removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002183416-2018-00003 |
| MDR Report Key | 7974092 |
| Report Source | CONSUMER |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-16 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-06-25 |
| Date Added to Maude | 2018-10-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PAXIA HER |
| Manufacturer Street | 11750 12TH AVE S. |
| Manufacturer City | BURNSVILLE MN 55337 |
| Manufacturer Country | US |
| Manufacturer Postal | 55337 |
| Manufacturer Phone | 9528088364 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KROGER SILICONE EAR PLUG |
| Generic Name | SILICONE EAR PLUGS |
| Product Code | EWD |
| Date Received | 2018-10-17 |
| Model Number | K10-67 |
| 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. Required No Informationntervention | 2018-10-17 |