MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-01-19 for VENTURI MASK KIT ADULT 3120-E manufactured by Unomedical Inc..
[17248534]
In 2005 unomedical's official correspondent rec'd a complaint from qa technician. Rec'd a complaint over a defective venturi mask kit. No incident occurred due to vigilance by the nursing personnel. The problem was a part of the venturi mask kit was not perforated which resulted in the venturi mask kit not feeding the intended oxygen concentration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2006-00001 |
| MDR Report Key | 667564 |
| Report Source | 01 |
| Date Received | 2006-01-19 |
| Date of Report | 2006-01-17 |
| Date of Event | 2005-11-23 |
| Date Mfgr Received | 2005-12-20 |
| Date Added to Maude | 2006-01-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | EFRAIN CARRERO, OFFICIAL CORRESP |
| Manufacturer Street | 6001 SOUTH 35TH STREET, STE B |
| Manufacturer City | MCALLEN TX 78503 |
| Manufacturer Country | US |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | 9566838472 |
| Manufacturer G1 | UNOMEDICAL S.A DE C.V. |
| Manufacturer Street | PARQUE INDUSTRIAL DEL NORTE SECCION 4, LOTE NO.7 |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTURI MASK KIT ADULT |
| Generic Name | VENTURI MASK KIT ADULT |
| Product Code | BYF |
| Date Received | 2006-01-19 |
| Model Number | 3120-E |
| Catalog Number | 3120-E |
| Lot Number | 05-28 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 656930 |
| Manufacturer | UNOMEDICAL INC. |
| Manufacturer Address | * MC ALLEN TX 78503 US |
| Baseline Brand Name | VENTURI MASK KIT ADULT, ALL DILUTERS |
| Baseline Generic Name | VENTURI MASK KIT, ALL DILUTERS |
| Baseline Model No | 3120-E |
| Baseline Catalog No | 3120-E |
| Baseline ID | NA |
| Baseline Device Family | OXYGEN MASK |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K780626 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-19 |