MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for COOLEY DILATOR 6/SET 355315 manufactured by Teleflex Medical.
[110584681]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[110584682]
It was the reported that the device was rough and sticking to the vessel and they soaked the dilators with heparin/saline solution. After completing surgery, the doctor inspected the saved vessel and noticed that there was a tear inside the vessel. The doctor inspected the dilators and noticed that on size 2 had a grainy, sand like texture and the dilators are supposed to be smooth. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00141 |
| MDR Report Key | 7578492 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-06-07 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOLEY DILATOR 6/SET |
| Product Code | DWP |
| Date Received | 2018-06-07 |
| Returned To Mfg | 2018-06-12 |
| Catalog Number | 355315 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-07 |