MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for SPEEDBAND SUPERVIEW SUPER 7 M00542253 4225-40 manufactured by Boston Scientific Corporation.
[184758536]
(b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184758538]
Hold 3 24 gtit was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the bands were attempted to be deployed; however, the elastic bands wound not deploy. Reportedly, the scope was withdrawn, and the procedure was completed with another speedband superview super 7 device. It was noted that there was no difficulty experienced upon setting up the device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01277 |
| MDR Report Key | 9871905 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPEEDBAND SUPERVIEW SUPER 7 |
| Generic Name | LIGATOR, HEMORRHOIDAL |
| Product Code | FHN |
| Date Received | 2020-03-24 |
| Model Number | M00542253 |
| Catalog Number | 4225-40 |
| Lot Number | 0024657891 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |