MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE manufactured by Andover Healthcare, Inc..
[46685475]
The wrap has a noxious odor, perhaps petroleum based? It was so strong, i had to remove the wrap and the clothes over it. My eyes stung there was no warning regarding use over non-intact skin or any other situation. Anything that smells that badly, must have to be detoxified by the liver or kidney.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062654 |
| MDR Report Key | 5700329 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-11 |
| Date Added to Maude | 2016-06-06 |
| 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 | 0 |
| Brand Name | POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE |
| Generic Name | POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE |
| Product Code | FQM |
| Date Received | 2016-06-02 |
| ID Number | 1001 W (STAMPED ON PKG) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANDOVER HEALTHCARE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |