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 2020-03-12 for TRIA FIRM M0061902230 1983-01 manufactured by Boston Scientific Corporation.
[188407313]
Date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event. (b)(6). (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
[188407314]
It was reported to boston scientific corporation that a tria ureteral stent was opened for use in an unknown procedure on an unknown date. According to the complainant, during unpacking, it was noticed that a foreign matter that seemed to be hair was found inside the sterile bag. The procedure was successfully completed with another tria ureteral stent. There were no patient complications reported as a result of this event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00899 |
| MDR Report Key | 9824947 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-03-06 |
| Date Added to Maude | 2020-03-12 |
| 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 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIA FIRM |
| Generic Name | STENT, URETERAL |
| Product Code | FAD |
| Date Received | 2020-03-12 |
| Model Number | M0061902230 |
| Catalog Number | 1983-01 |
| Lot Number | 0023432021 |
| 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 | 2020-03-12 |