MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-15 for KNIFE BLADE NO BRAND NAME manufactured by Medline.
[1424541]
Performing bilateral lumbar laminotomies at l3 and l4-5 and end of procedure, knife blade tip broke off resting on l4-5. No harm to patient at time and no anticipation of further harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014773 |
| MDR Report Key | 1609412 |
| Date Received | 2010-02-15 |
| Date of Report | 2010-02-15 |
| Date of Event | 2010-02-10 |
| Date Added to Maude | 2010-03-12 |
| 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 | KNIFE BLADE NO BRAND NAME |
| Generic Name | KNIFE BLADE |
| Product Code | EMF |
| Date Received | 2010-02-15 |
| Lot Number | DYNJ2214B |
| ID Number | NEUROPACK LOT# |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-15 |