MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for BOSTON SCIENTIFIC 7 BANDS manufactured by Boston Scientific Corporation.
[183132260]
The physician checked the bander outside of pt to make sure that it deployed correctly and it did when he went into the pt and suctioned the varices ready to deploy the bander, it malfunctioned and did not deploy the second time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093631 |
| MDR Report Key | 9810848 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-05 |
| Date Added to Maude | 2020-03-10 |
| 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 | BOSTON SCIENTIFIC 7 BANDS |
| Generic Name | LIGATOR, ESOPHAGEAL |
| Product Code | MND |
| Date Received | 2020-03-09 |
| Model Number | 7 BANDS |
| Lot Number | 25015387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |