MAUDE Adverse Event Report: UNOMEDICAL S.R.O. ICU/O2 & AEROSOL/CATHETER; CATHETER, NASAL, OXYGEN

Model Number 19017182

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Swelling (2091)

Event Date 02/27/2014

Event Type  Injury  

Event Description

Complainant reported catheter cause irritation and swelling with one pt.

Manufacturer Narrative

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.

• Brand Name: ICU/O2 & AEROSOL/CATHETER
• Type of Device: CATHETER, NASAL, OXYGEN
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 0710 1; LO 07101
• Manufacturer Contact: matthew walenciak, assoc dir ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042287
• MDR Report Key: 3712767
• MDR Text Key: 4251802
• Report Number: 3005778470-2014-00011
• Device Sequence Number: 1
• Product Code: BZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: 19017182
• Device Catalogue Number: 19017182
• Device Lot Number: 441639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention