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 2019-01-08 for JINRO PIGTAIL M0064202020 420-202 manufactured by Boston Scientific Corporation.
[132372411]
The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown. (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
[132372412]
It was reported to boston scientific corporation that a jinro pigtail device was used during a procedure performed on an unknown date. According to the complainant, a jinro pigtail device was placed in the patient several weeks ago. On (b)(6) 2018 it was noted that the device fell out. There were no patient complications reported as a result of this event. Attempts to obtain additional patient and procedure information have been unsuccessful. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62458 |
| MDR Report Key | 8226626 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-08 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2019-02-01 |
| Date Added to Maude | 2019-01-08 |
| 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 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 | JINRO PIGTAIL |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2019-01-08 |
| Returned To Mfg | 2019-01-04 |
| Model Number | M0064202020 |
| Catalog Number | 420-202 |
| 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 CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |