MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for T-DOC URODYNAMIC CATHETER manufactured by .
[74756132]
Steris ast received (b)(4) regarding a t-doc urodynamic catheter. The product subject of the medwatch report is not manufactured by steris ast. Steris ast contacted the user facility to determine the manufacturer of the device subject of the medwatch. The medwatch report will be forwarded to the manufacturer of the device for purposes of investigation and evaluation for potential medical device reporting under 21 cfr 803.
Patient Sequence No: 1, Text Type: N, H10
[74756133]
Reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720929-2017-00001 |
| MDR Report Key | 6549358 |
| Date Received | 2017-05-05 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-05-05 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 3303927231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T-DOC URODYNAMIC CATHETER |
| Generic Name | CATHETER |
| Product Code | FEN |
| Date Received | 2017-05-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-05 |