MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-06-10 for HUDSON AEROSOL ELONGATED ADULT MASK 1083 manufactured by Teleflex Medical.
[3540456]
The complaint was reported as: the customer alleges that the hudson mask is not fitting into the fisher and paykel rt 202 humidification/blender tubing very easily and it fall out or comes apart during use. No report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
[10817296]
A visual inspection of the product involved in the complaint could not be conducted since the product was not returned. In order to perform a proper investigation it is necessary to evaluate the sample involved in the incident. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record (dhr) for the reported lot number (02k1101804) was reviewed and no non conformance reports were originated for the lot in question that can be associated to the complaint reported. The customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident. If the defective sample becomes available this investigation will be updated with the eval results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00195 |
| MDR Report Key | 3165399 |
| Report Source | 01,06,07 |
| Date Received | 2013-06-10 |
| Date of Report | 2013-05-17 |
| Date of Event | 2013-05-16 |
| Date Mfgr Received | 2013-05-17 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2013-09-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RA CLINICAL SPECI |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 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 AEROSOL ELONGATED ADULT MASK |
| Generic Name | AEROSOL MASK |
| Product Code | CBP |
| Date Received | 2013-06-10 |
| Catalog Number | 1083 |
| Lot Number | 02K1101804 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-10 |