MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-10 for HUDSON ET TUBE HOLDER, STANDARD 81801 manufactured by Teleflex Medical Sdn. Bhd..
[178367595]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178367596]
Customer reported the foam on the upper lip of the device fell off and was found in the patient's bed, mouth, or hanging loose. The device was replaced. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00035 |
| MDR Report Key | 9686841 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-02-10 |
| 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 SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 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 ET TUBE HOLDER, STANDARD |
| Generic Name | TRACHEAL TUBE FIXATION DEVICE |
| Product Code | CBH |
| Date Received | 2020-02-10 |
| Catalog Number | 81801 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |