MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for RELIEVA SPINPLUS RSP0616MFS manufactured by Acclarent, Inc..
[177374704]
Staff reported to the charge nurse that the wire of the device would not slide properly and that it was "sticking". Device was removed from service and replaced with a new sterile supply. The device was given to materials management to handle a return to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659244 |
| MDR Report Key | 9659244 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-10-23 |
| Report Date | 2019-11-12 |
| Date Reported to FDA | 2019-11-12 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RELIEVA SPINPLUS |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2020-02-03 |
| Model Number | RSP0616MFS |
| Catalog Number | RSP0616MFS |
| Lot Number | 190509A-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DR. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |