MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-17 for TUBAL LUMEN SUPPORT N/A J-TLS-305000 manufactured by Cook Inc.
[38999797]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[38999798]
During the procedure, part of the tubal lumen support catheter migrated outside of the fallopian tube. Additional information has been requested, but not provided at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[55604184]
(b)(4). Initial was filed within the 30 day time frame regardless of corrected date (additional information provided/updated): investigation/evaluation: the complaint product was not returned to assist in the investigation; however, during the course of the investigation, a review of the complaint history, quality control, and instructions for use (ifu) of the product was conducted. The customer reported that "part of the device migrated outside of the fallopian tube. " additional information provided (b)(6) 2016 stated "it was determined that the tube was completely intact so no further action is needed. " the tubal lumen support is intended to provide "support to the fallopian tube during an anastomosis procedure. " an ifu is provided with this device. Additional information has been requested (b)(6) 2016 as to whether to "intact tube" was referring to the fallopian tube or the medical device. As of (b)(6) 2016, this information has not been provided. It is reasonable to assume based on the customer's provided statement on (b)(6) 2016 that the tube had not separated into two sections. Based on the limited information provided, a root cause could not be determined. We have notified the appropriate personnel and will continue to monitor for similar complaints. Per the risk assessment, no further risk reduction activities are required.
Patient Sequence No: 1, Text Type: N, H10
[55604185]
During the procedure, part of the tubal lumen support catheter migrated outside of the fallopian tube. Additional information was provided that the tube was completely intact. No information was provided regarding patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00129 |
| MDR Report Key | 5441092 |
| Date Received | 2016-02-17 |
| Date of Report | 2016-01-28 |
| Date Mfgr Received | 2016-01-28 |
| Date Added to Maude | 2016-02-17 |
| 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 | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBAL LUMEN SUPPORT |
| Generic Name | HFJ PROSTHESIS, FALLOPIAN TUBE |
| Product Code | HFJ |
| Date Received | 2016-02-17 |
| Model Number | N/A |
| Catalog Number | J-TLS-305000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-17 |