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 2018-10-23 for HUDSON MASK,MEDIUM CONC,ELONG,PED 1042 manufactured by Teleflex Medical.
[124817731]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[124817732]
Customer complaint alleges "the tubing is coming apart at the mask connection. " alleged issue reported occurred during use. No patient injury or consequence reported. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00323 |
| MDR Report Key | 7995927 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2018-07-03 |
| Date Added to Maude | 2018-10-23 |
| 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 | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON MASK,MEDIUM CONC,ELONG,PED |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2018-10-23 |
| Returned To Mfg | 2018-10-08 |
| Catalog Number | 1042 |
| Lot Number | 74G1800724 |
| 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 | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-23 |