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 2018-05-15 for URETHRAL DILATOR SET 073701 manufactured by Cook Inc.
[108360340]
(b)(6). (b)(4). This report includes information known at this time.? A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[108360341]
It was reported that a hair can be seen in the pouch which the urethral dilator set was packaged in. Therefore, the user didn't use the urethral dilator set as the sterilization may have been compromised. There were no adverse consequences to the patient as a result of this reported issue. The device did not make contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01474 |
| MDR Report Key | 7515876 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-15 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-05-15 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URETHRAL DILATOR SET |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-05-15 |
| Catalog Number | 073701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-15 |