MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-12-10 for ICU/O2 AND AEROSOL/CATHETER 19013181 manufactured by Unomedical S.r.o..
[3971953]
Information received via complaint form indicates the following: "some of the allergic reaction was considered somewhat serious by the reporting health care provider. This report includes two or more patients in anesthesia and surgical department. "
Patient Sequence No: 1, Text Type: D, B5
[11381475]
Based on the available information, the event is deemed a serious injury. It is reported that "some of the allergic reaction was considered somewhat serious by the reporting hcp. " it is also reported that the device has been discontinued from use. An investigation was conducted based on the information provided by the customer. The results of the investigation indicate following. The samples have not been available for evaluation; therefore, the investigation has been conducted based on the device history records. Device history files have been checked. The results of review showed that all relevant tests performed during a manufacturing process and final product release and been fulfilled and met the requirements. No nonconformity has been registered during a manufacturing process as well as packaging process. No further complaint has been received on the batch in question. There are no changes of material and components use for production process. We have not received other complaint of this nature in connection with the ref code within last 24 months. The product group what includes product in question is safe to use according to iso 10993, based on the material assessment and based on the conclusions from the biocompatibility testing for the product groups. No additional patient/event details have been provided to date. Should additional information becomes available, a follow up report will be submitted. . Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2013-00056 |
| MDR Report Key | 3521612 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-11-11 |
| Date Mfgr Received | 2013-11-11 |
| Date Added to Maude | 2013-12-17 |
| 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 | MARY SZARO, ASSO DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICU/O2 AND AEROSOL/CATHETER |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2013-12-10 |
| Model Number | 19013181 |
| Catalog Number | 19013181 |
| Lot Number | 446638 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-10 |