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 KIDS KROGER SILICONE EAR PLUGS C265STKG manufactured by Apothecary Products, Llc.
[123987230]
The package label provides the following information: "these ear plugs are sized to cover tiny ear canals only - use our adult size to cover larger ear canals. Directions for effective and comfortable use: with clean hands, roll plug between fingers to soften. Use entire plug. Shape plugs into a ball. Place plugs against ear openings and flatten firmly. Just cover ear opening. Do not force into ear canal. Safety warnings: not recommended for overnight use, diving, prolonged underwater swimming, or depths over 10 feet. Although these plugs are not intended for use as hearing protectors, they will help block sound when properly sealed. In case of airplane use, remove prior to descent. If you should experience pain or discomfort when using this product, please discontinue use. Caution: inspect product before use and replace plugs if they are damaged or show signs of wear. Not for prolonged use. Do not cut, stretch or break apart ear plugs. If not used as directed, ear plug could become trapped in ear canal requiring surgical removal by a qualified professional. If ear plug has become lodged in ear canal, do not try to remove with tweezers or any other device. Seek medical attention for proper removal. Please note - a few days delay will cause no harm. Warning: keep ear plugs away from infants and small children as they may get caught in the windpipe and create a choking hazard. Use by children should be closely supervised by adults. "
Patient Sequence No: 1, Text Type: N, H10
[123987231]
User's guardian stated after use of the silicone earplug, it could not be removed from the user's ear canals and kept breaking apart upon removal. The user's guardian stated they tried using tweezers to remove the ear plugs. The user went to the emergency room where suction methods were used to try to remove the silicone ear plugs. The user had to get the silicone ear plugs surgically extracted with anesthesia for removal from the ear canals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002183416-2018-00001 |
| MDR Report Key | 7974233 |
| Report Source | CONSUMER |
| Date Received | 2018-10-17 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-26 |
| Date Mfgr Received | 2018-08-29 |
| 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 | MR 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 |
| Brand Name | KIDS KROGER SILICONE EAR PLUGS |
| Generic Name | SILICONE EAR PLUGS |
| Product Code | EWD |
| Date Received | 2018-10-17 |
| Model Number | C265STKG |
| 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 |