MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-11 for BIG FOOT CANE TIP SM-017003B T20009 manufactured by Skymed Supply International Corporation.
| Report Number | 1056127-2019-00004 |
| MDR Report Key | 9306694 |
| Date Received | 2019-11-11 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-10-01 |
| Date Facility Aware | 2019-10-14 |
| Report Date | 2019-11-11 |
| Date Reported to FDA | 2019-11-11 |
| Date Reported to Mfgr | 2019-11-11 |
| Date Added to Maude | 2019-11-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIG FOOT CANE TIP |
| Generic Name | CANE TIP |
| Product Code | INP |
| Date Received | 2019-11-11 |
| Model Number | SM-017003B |
| Catalog Number | T20009 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYMED SUPPLY INTERNATIONAL CORPORATION |
| Manufacturer Address | 6905 ARAGON CIRCLE BUENA PARK CA 90620 US 90620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-11 |