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 2019-04-30 for COMPLIANCE ENDOKIT CEK-880-20 2088-06 manufactured by Boston Scientific Corporation.
[143618181]
The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143618182]
It was reported to boston scientific corporation that a compliance endokit was used on (b)(6) 2019. According to the complainant, during preparation, when the technician opened the kit, there were overwhelming fumes which caused the technician to have an allergic reaction. The technician was taken to the emergency room. It is unknown as to what treatment was given to the technician in the emergency room however they were reported to be fine and stable following treatment. There was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02296 |
| MDR Report Key | 8566835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-30 |
| 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 | 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 | 2019-04-30 |
| Model Number | CEK-880-20 |
| Catalog Number | 2088-06 |
| 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 | 1. Hospitalization | 2019-04-30 |