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 2018-05-01 for FLEXIMA? APDL M001271380 27-138 manufactured by Boston Scientific - Costa Rica (coyol).
[107080164]
(b)(4). Device evaluated by manufacturer: the device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107080165]
It was reported that drain was implanted in the chest when hub detached. The target lesion was located in the chest. A flexima? Apdl was selected for use. The drain was successfully placed in the patient's chest in the interventional radiology (ir) suite. Then patient was taken back to the room. At some point, when the nurse checked on the drain, it was noted that the white hub of the drain was separated from the catheter and hanging by the locking wire. Patient was then taken back to ir to place another drainage catheter back inside the patient. No patient complications reported and patient's status was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-04166 |
| MDR Report Key | 7478063 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2017-09-21 |
| Date Added to Maude | 2018-05-01 |
| 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? APDL |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-05-01 |
| Model Number | M001271380 |
| Catalog Number | 27-138 |
| Lot Number | 21154791 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-01 |