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 2018-11-26 for COMPLIANCE ENDOKIT CEK-799-20 2088-03 manufactured by Boston Scientific Corporation.
[128312609]
(b)(4). The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[128312610]
It was reported to boston scientific corporation that a compliance endokit was used on (b)(6) 2018. According to the complainant, when the kit was opened, there was a small bug inside the package. The kit was disposed and another compliance endokit was used to complete the procedure. There was no serious injury nor adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61565 |
| MDR Report Key | 8102482 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | ENDOCHOICE |
| Manufacturer Street | 11810 WILLS ROAD , |
| Manufacturer City | ALPHARETTA GA 30009 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPLIANCE ENDOKIT |
| Generic Name | CONVENIENCE KIT |
| Product Code | MNL |
| Date Received | 2018-11-26 |
| Model Number | CEK-799-20 |
| Catalog Number | 2088-03 |
| Lot Number | 0000228937 |
| 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 | 100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-26 |