MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-10-22 for HUDSON AIR CUSHION MASK W/VALVE,LARGE ADULT 1282 manufactured by Teleflex Medical.
[124576904]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[124576905]
Customer complaint alleges a leak was detected in the mask during inspection/functional testing prior to use on a patient. No patient involvement reported. No patient impact or consequence reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00280 |
| MDR Report Key | 7991614 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-10-22 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON AIR CUSHION MASK W/VALVE,LARGE ADULT |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATIO |
| Product Code | BSJ |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-10-17 |
| Catalog Number | 1282 |
| Lot Number | 171208 |
| 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 | 2018-10-22 |