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 2019-01-02 for FLEXIMA APDL 30935 manufactured by Boston Scientific Corporation.
[131836060]
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Patient Sequence No: 1, Text Type: N, H10
[131836061]
It was reported that the patient experienced serious injury. The pigtail of the flexima apdl remained locked even in an unlocked position. Consequently, a serious injury occurred due to the difficulty in removing the pigtail drain. No further patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-64682 |
| MDR Report Key | 8209625 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2019-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| 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 | 2019-01-02 |
| Model Number | 30935 |
| Catalog Number | 30935 |
| Lot Number | 0021689435 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-02 |