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 2019-02-19 for UROMAX ULTRA KIT M0062251220 225-122 manufactured by Boston Scientific Corporation.
[136539524]
(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
[136539545]
It was reported to boston scientific corporation that a uromax ultra dilatation balloon was used during a stone extraction procedure performed last (b)(6) 2019. According to the complainant, during preparation, the device pouch was torn while opening the package and the sterile seal was compromised. Reportedly, this might be due to manufacture defect. The procedure was completed with another uromax ultra dilatation balloon. There were no patient complications reported as a result of this event. The patients condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00738 |
| MDR Report Key | 8350670 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2017-08-10 |
| Date Added to Maude | 2019-02-19 |
| 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 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROMAX ULTRA KIT |
| Generic Name | DILATOR, CATHETER, URETERAL |
| Product Code | KOE |
| Date Received | 2019-02-19 |
| Model Number | M0062251220 |
| Catalog Number | 225-122 |
| Lot Number | 0020992581 |
| 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 | 2019-02-19 |