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 2019-02-11 for HEDGEHOG SBD-228-50 60252 manufactured by Boston Scientific Corporation.
[135890853]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. This is a non-sterile device with no expiration date. (b)(4). Although the suspect device has been received for analysis, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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
[135890854]
It was reported to boston scientific corporation that a hedgehog double-end brush was used on (b)(6) 2019. According to the complainant, during scope reprocessing, the bristles from the hedgehog brush detached in the scope. The bristles were removed manually from the scope. It was reported that another hedgehog brush was used to complete scope cleaning. There was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00640 |
| MDR Report Key | 8329495 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-11 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-02-11 |
| 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 | SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD |
| Manufacturer Street | NO 699 PINAN ROAD PUZHAUNG LINHU TOWN, |
| Manufacturer City | WUZHONG DISTRICT, SUZHOU 21505 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 21505 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEDGEHOG |
| Generic Name | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Product Code | MNL |
| Date Received | 2019-02-11 |
| Returned To Mfg | 2019-01-24 |
| Model Number | SBD-228-50 |
| Catalog Number | 60252 |
| 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 | 2019-02-11 |