MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for SYMPHION FLUID MANAGEMENT ACCESSORIES FG-0202 manufactured by Boston Scientific.
[102208490]
Symphion disposables not recognized by machine. Advised this has been an issue with certain lot numbers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075794 |
| MDR Report Key | 7330406 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-03-08 |
| Date Added to Maude | 2018-03-12 |
| 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 |
| 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 | SYMPHION FLUID MANAGEMENT ACCESSORIES |
| Generic Name | INSULFFLATOR HYSTEROSCOPIC FLUID, CLOSED-LOOP |
| Product Code | PGT |
| Date Received | 2018-03-09 |
| Returned To Mfg | 2018-03-08 |
| Model Number | FG-0202 |
| Catalog Number | FG-0202 |
| Lot Number | 64091864 |
| Device Expiration Date | 2018-12-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Brand Name | SYMPHION FLUID MANAGEMENT |
| Generic Name | SYMPHION FLUID MANAGEMENT |
| Product Code | PGT |
| Date Received | 2018-03-09 |
| Returned To Mfg | 2018-03-08 |
| Model Number | FG-0202 |
| Catalog Number | FG-0202 |
| Lot Number | 66757822 |
| Device Expiration Date | 2019-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |