MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for NEURAY SURGICAL PADDIES 1/2" X 1/2" 8004000 manufactured by Medtronic Xomed, Inc..
[174500579]
During an arthroplasty a device's paddies were coming off of the [invalid]. This was identified by an rn during the procedure so it did not affect our pt. The product was ref # 800400 nueray 200pk 13x13mm paddies. Lot number 00030431. We have pulled the remaining paddies off of the shelf. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092100 |
| MDR Report Key | 9569073 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-19 |
| Date Added to Maude | 2020-01-09 |
| 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 | 3 |
| Brand Name | NEURAY SURGICAL PADDIES 1/2" X 1/2" |
| Generic Name | NEUROSURGICAL PADDIE |
| Product Code | HBA |
| Date Received | 2020-01-08 |
| Model Number | 8004000 |
| Lot Number | 00030431 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |