MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for 3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER 34-8721-5433-0/0917 manufactured by 3m Company.
[178585480]
I purchased a 3m futuro support brace on (b)(6) 2019. I used it to support an arthritic left knee when i exercise at my fitness center. During exercise on (b)(6) 2020, i noticed a sharp pain on the left side of my knee cap. When i removed the support brace, i noticed that the steel stabilizer mesh broke in half and pierced through the fabric digging into my knee. Later yesterday, i returned the support brace to (b)(6) and received a new one. The support brace does work well but the manufacturer should be made aware of the defect with the stabilizer and it? S ability to do bodily harm. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092850 |
| MDR Report Key | 9686612 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-04 |
| Date Added to Maude | 2020-02-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER |
| Generic Name | STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) |
| Product Code | DWL |
| Date Received | 2020-02-07 |
| Model Number | 34-8721-5433-0/0917 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |