MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for BLOX SBT-114-100 60264 manufactured by Boston Scientific Corporation.
[145599494]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown. (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145599495]
It was reported to boston scientific corporation that a blox bite block was used on (b)(6) 2019. According to the complainant, after placing the bite block on the patient's mouth after sedation, a snapping sound was heard. The device was found broken and a fragment fell into the stomach. The broken fragment was removed from the patient's stomach using forceps. Another bite block 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 | 3005099803-2019-02564 |
| MDR Report Key | 8625014 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-06-19 |
| Date Added to Maude | 2019-05-20 |
| 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 | JIANGSU JIANYU HEALTH MEDICAL CO LTD |
| Manufacturer Street | ZHIXI INDUSTRY ZONE JINTAN AREA, |
| Manufacturer City | CHANGZHOU CITY 213251 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 213251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLOX |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-05-28 |
| Model Number | SBT-114-100 |
| Catalog Number | 60264 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-20 |