MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2014-03-25 for ICU/O2 & AEROSOL/CATHETER 19017182 manufactured by Unomedical S.r.o..
[4251802]
Complainant reported catheter cause irritation and swelling with one pt.
Patient Sequence No: 1, Text Type: D, B5
[11725366]
Based on the available info, this event is deemed a serious injury. Additional pt/event info was requested on (b)(4) 2014. To date no additional info has been received. Should additional pt/event info become available a follow-up report will be submitted. Note: the actual date of event is unk, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00011 |
| MDR Report Key | 3712767 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2014-04-01 |
| 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 | MATTHEW WALENCIAK, ASSOC DIR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICU/O2 & AEROSOL/CATHETER |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2014-03-25 |
| Model Number | 19017182 |
| Catalog Number | 19017182 |
| Lot Number | 441639 |
| Device Expiration Date | 2017-03-01 |
| 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 | 2014-03-25 |