MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-06 for GAIT IMPLANT 30-100-03 manufactured by Sgarlato Labs.
[3184510]
The outer packaging has an expiration date of 05/2013. The inner packaging has an expiration date of 08/2007. Close examination of the outer packaging shows that a label was placed over the original expiration date. This implant was not used on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029010 |
| MDR Report Key | 2969223 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-02-06 |
| Date of Event | 2013-01-31 |
| Date Added to Maude | 2013-02-21 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | GAIT IMPLANT |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2013-02-06 |
| Model Number | 30-100-03 |
| Lot Number | 091103A 051700 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SGARLATO LABS |
| Manufacturer Address | 2315 S. BASCOM AVE #200 CAMPBELL CA 95008 US 95008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-06 |