MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-29 for MEDTRONIC INFUSE BONE GRAFT 7510100 manufactured by Medtronic.
[6830052]
The medtronic infuse bone graft x-small kit (b)(4), lot # m111350aad has an expiration date on the outside of the box in addition to different expiration dates on the three bottles contained inside the box. This is confusing to staff in checking for product expiration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043582 |
| MDR Report Key | 4895151 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-29 |
| Date Added to Maude | 2015-07-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDTRONIC INFUSE BONE GRAFT |
| Generic Name | MEDTRONIC INFUSE BONE GRAFT |
| Product Code | NPZ |
| Date Received | 2015-06-29 |
| Catalog Number | 7510100 |
| Lot Number | M111305AAD |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-29 |