MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-20 for HUDSON HCH ASSY,AQUA+ 1571 manufactured by Teleflex Medical.
[117588927]
(b)(4). The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[117588928]
Customer complaint alleges the device broke apart during a patient use. No patient injury or consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00221 |
| MDR Report Key | 7797149 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-09-28 |
| Date Added to Maude | 2018-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON HCH ASSY,AQUA+ |
| Generic Name | CONDENSER, HEAT AND MOISTURE ( |
| Product Code | BYD |
| Date Received | 2018-08-20 |
| Returned To Mfg | 2018-08-30 |
| Catalog Number | 1571 |
| Lot Number | 201749 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |