MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for MUELLER WRIST BRACE 222 manufactured by 2110420.
[104530806]
Consumer claims brace has been problematic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110420-2017-00001 |
| MDR Report Key | 7401249 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2018-04-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIN DALY |
| Manufacturer Street | ONE QUENCH DRIVE PO BOX 99 |
| Manufacturer City | PRARIE DU SAC 53578 |
| Manufacturer Country | US |
| Manufacturer Postal | 53578 |
| Manufacturer Phone | 6086438530 |
| Manufacturer G1 | MUELLER SPORTS MEDICINE |
| Manufacturer Street | ONE QUENCH DRIVE PO BOX 99 |
| Manufacturer City | PRARIE DU SAC 53578 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53578 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MUELLER WRIST BRACE |
| Generic Name | MUELLER WRIST BRACE |
| Product Code | IQI |
| Date Received | 2018-04-05 |
| Model Number | 222 |
| Catalog Number | 222 |
| Lot Number | 000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 2110420 |
| Manufacturer Address | ONE QUENCH DRIVE PO BOX 99 PRARIE DU SAC 53578 US 53578 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-05 |