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 2018-07-27 for FLEXIMA? M001271800 27-180 manufactured by Boston Scientific - Costa Rica (coyol).
[115367019]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115367020]
Same case as mdr id: 2134265-2018-07013. It was reported that foreign matter was observed on the device. Two 10. 3 flexima drainage catheters were selected for use. During the procedure, the physician put two flexima catheters in the patient; however, it was noted that both catheters leaked around the hub. It was further noted that there was like a small piece of a thread coming out of the catheter hub where the physician thought it was leaking. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-07014 |
| MDR Report Key | 7726671 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-05 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2018-07-27 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA? |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-07-27 |
| Returned To Mfg | 2018-07-13 |
| Model Number | M001271800 |
| Catalog Number | 27-180 |
| Lot Number | 22056318 |
| 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 - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |