MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for SPEEDBAND SUPERVIEW SUPER 7 M00542250 manufactured by Boston Scientific Corporation.
[181529121]
Two separate banders did not deploy. 2 to 3 bands out of each bander did not deploy correctly when fired during egd esophageal variceal banding. Package available to review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093276 |
| MDR Report Key | 9753462 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-20 |
| Date Added to Maude | 2020-02-26 |
| 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 | SPEEDBAND SUPERVIEW SUPER 7 |
| Generic Name | LIGATOR, ESOPHAGEAL |
| Product Code | MND |
| Date Received | 2020-02-25 |
| Model Number | M00542250 |
| Lot Number | 24776479 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Brand Name | SPEEDBAND SUPERVIEW SUPER 7 |
| Generic Name | LIGATOR, ESOPHAGEAL |
| Product Code | MND |
| Date Received | 2020-02-25 |
| Model Number | M00542250 |
| Lot Number | 24625167 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |