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 FASCIADERM 6337 manufactured by Mueller Sports Medicine, Inc..
[36027859]
Good faith efforts are being made to obtain additional information. Mueller will send follow up report if additional input is received. This issue will be monitored through the complaints and capa system within mueller's quality management system. Classification : class i exempt.
Patient Sequence No: 1, Text Type: N, H10
[36027860]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110420-2015-00003 |
| MDR Report Key | 5366370 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-02-04 |
| 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 | FASCIADERM |
| Generic Name | PLANTAR FASCILITIS PAIN RELIEF SYSTEM |
| Product Code | FQM |
| Date Received | 2016-01-06 |
| Model Number | 6337 |
| Catalog Number | 6337 |
| Lot Number | NA |
| 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 |