MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-14 for EQUATE manufactured by .
[1761874]
Reporter applied spacers on (b)(6) 2010 and said when he removed spacers on (b)(6) 2010 the spacer was hard to remove due to a sticky substance on the spacer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018582 |
| MDR Report Key | 1929708 |
| Date Received | 2010-12-14 |
| Date of Report | 2010-12-14 |
| Date of Event | 2010-12-13 |
| Date Added to Maude | 2010-12-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUATE |
| Generic Name | TOE SPACERS (GEL) |
| Product Code | MNE |
| Date Received | 2010-12-14 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-14 |