MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-13 for HUDSON MASK,HIGH CONC,ADULT,INTL 41007 manufactured by Teleflex Medical.
[139192501]
Qn# (b)(4). The device involved was not returned for evaluation by the manufacturer. The device history record of batch number 74k1602223 that belongs to catalog number 41007 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Customer complaint cannot be confirmed based only on the information provided. To perform a proper and thorough investigation, it is necessary to evaluate the sample involved in this complaint. Root cause cannot be determined. Corrective actions cannot be established. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[139192502]
Customer complaint reads: "for a patient under 15 liters, the balloon does not inflate or very little. Another mask was used but with the same issue. The patient desaturated until 77%. Using the other mask the saturation went back up to 88% but with difficulties". (first event captured in mdr #3004365956-2019-00070). Clinical consequences reported "desaturation of the patient. A mask from an ambulance was used and the saturation went back up to normal and the balloon was perfectly inflated. I don't know what was the device used by ambulance".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00069 |
| MDR Report Key | 8416844 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2019-03-13 |
| 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 | PHARMACIST |
| 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,HIGH CONC,ADULT,INTL |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2019-03-13 |
| Catalog Number | 41007 |
| Lot Number | 74K1602223 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |