MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for V. MUELLER NEURO / SPINE SHADOW-LINE T-0101 manufactured by Becton Dickinson And Company.
[116451879]
During a procedure, a piece of the shadow line frame fell apart while being used for retraction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078903 |
| MDR Report Key | 7757383 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-31 |
| Date Added to Maude | 2018-08-07 |
| 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 |
| 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 | 0 |
| Brand Name | V. MUELLER NEURO / SPINE SHADOW-LINE T-0101 |
| Generic Name | RETRACTOR, SELF-RETAINING |
| Product Code | FFO |
| Date Received | 2018-08-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-06 |