MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-14 for FLEXIMA? APDL M001271340 27-134 manufactured by Boston Scientific - Costa Rica (coyol).
[111072944]
Age at time of event: 18 years or older. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111072945]
It was reported that the suture was broken. A flexima? Apdl was selected for use. During the procedure, when the physician pulled on the suture to lock the pigtail, it was noted that the suture snapped. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-05269 |
| MDR Report Key | 7601881 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-14 |
| Date of Report | 2018-05-23 |
| Date Mfgr Received | 2018-07-11 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2018-06-14 |
| 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 | 2018-06-14 |
| Returned To Mfg | 2018-05-29 |
| Model Number | M001271340 |
| Catalog Number | 27-134 |
| Lot Number | 21805168 |
| 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 | 2018-06-14 |