MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-05 for ENCORE 26 3040 manufactured by Boston Scientific Corporation.
[179237774]
It was reported that the opening seal flap part was torn off. A encore 26 inflation device was selected for use. It was noted that the opening seal was not peeled of, but the flap part was torn off indicating that the seal of the product box was found to be damaged. No complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00488 |
| MDR Report Key | 9672898 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-09-02 |
| Date Added to Maude | 2020-02-05 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK IRELAND |
| Manufacturer Country | EI |
| Manufacturer Postal Code | IRELAND |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCORE 26 |
| Generic Name | SYRINGE, BALLOON INFLATION |
| Product Code | MAV |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 3040 |
| Catalog Number | 3040 |
| Lot Number | 0024359925 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |