MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-26 for PHYSICIAN'S CHOICE 69876 manufactured by Apothecary Products, Llc.
| Report Number | 0002183416-2019-00007 |
| MDR Report Key | 8933125 |
| Report Source | CONSUMER |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-08-12 |
| Date Added to Maude | 2019-08-26 |
| 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 | PHYSICIAN'S CHOICE |
| Generic Name | EAR PROTECTOR |
| Product Code | EWD |
| Date Received | 2019-08-26 |
| Model Number | 69876 |
| Operator | LAY USER/PATIENT |
| 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 | 2019-08-26 |