MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for BLAKE CHANNEL DRAIN (15FR SILICONE) JP2188 manufactured by Cardinal Health 200, Llc.
[142892770]
Pt as one week postop with drain placement. Two days prior to event, she noted a change in the character of the suction of the drain and a stop in output. When the drain was removed in the office, it was clear that a portion of it was separated and stayed behind. An x-ray was performed and an attempt to retrieve the separated portion was done but surgery was required to remove the retained portion of drain. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086056 |
| MDR Report Key | 8540875 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-04-09 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLAKE CHANNEL DRAIN (15FR SILICONE) |
| Generic Name | INTRODUCTION DRAINAGE CATHETER AND ACCESSORIES |
| Product Code | GCD |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-18 |
| Model Number | JP2188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-22 |