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 2018-06-12 for HUDSON HUMID-FLO HME 19912 manufactured by Teleflex Medical.
[111025112]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111025113]
Customer complaint alleges "the connection is extremely loose and the respiratory therapists are needing to use silk tape to keep things together". There was no report of patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00153 |
| MDR Report Key | 7592376 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-12 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-06-12 |
| 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 | 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 HUMID-FLO HME |
| Generic Name | CONDENSER, HEAT AND MOISTURE ( |
| Product Code | BYD |
| Date Received | 2018-06-12 |
| Catalog Number | 19912 |
| Lot Number | 201801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-12 |