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 2018-12-13 for HEDGEHOG manufactured by Boston Scientific Corporation.
[130232009]
The complainant was unable to provide the suspect device upn and lot number; therefore, the expiration date, device manufacture date and udi number is unknown. (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
[130232010]
Note: this report pertains to one of two devices used in the same procedure. It was reported to boston scientific corporation that a hedgehog brush was found inside of a scope during a colonoscopy procedure on (b)(6) 2018. According to the complainant, during procedure, a brush was found stuck inside the suction port of the endoscope. The brush was removed using an endostat. A second scope was used and another brush was found in the suction port of that scope. The brush was removed from the second scope using forceps. A third scope was used to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61950 |
| MDR Report Key | 8160432 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-13 |
| 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 | 100 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| 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 | 2018-12-13 |
| 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 | 2018-12-13 |