MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-06 for MUELLER ADJUSTABLE ANKLE SUPPORT 4547 manufactured by Mueller Sports Medicine, Inc..
[36028477]
(b)(4 ): mueller sports medicine has reported this complaint voluntarily based on the issue of potential serious injury that could have been the result of the product coming in contact with consumers skin causing a skin reaction. Numberous attempts were made to gather more information from consumer without any success. This issue will be monitored through the complaints and capa system within mueller's quality management system. Complaint has been closed with no further action or investigation at this time. Classification: class i exempt.
Patient Sequence No: 1, Text Type: N, H10
[36028478]
Customer bought product from (b)(6) because the carton said latex free materials. She wore it for 2 days and had an extreme reaction that is similar to the one that she gets from latex. Numerous attempts to contact consumer did not produce additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110420-2015-00001 |
| MDR Report Key | 5366379 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-06 |
| Date of Report | 2016-12-01 |
| Date of Event | 2015-12-11 |
| Date Added to Maude | 2016-01-14 |
| 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 Street | 1 QUENCH DR. |
| Manufacturer City | PRAIRIE DU SAC WI 53578 |
| Manufacturer Country | US |
| Manufacturer Postal | 53578 |
| Manufacturer Phone | 6086438530 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MUELLER ADJUSTABLE ANKLE SUPPORT |
| Generic Name | ADJUSTABLE ANKLE SUPPORT |
| Product Code | ITW |
| Date Received | 2016-01-06 |
| Model Number | 4547 |
| Catalog Number | 4547 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUELLER SPORTS MEDICINE, INC. |
| Manufacturer Address | PRAIRIE DU SAC WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-06 |