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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 4008
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 11/19/2019
Event Type  Injury  
Event Description
It was reported that the skin portion of the right upper arm was itchy with a blistering area of about 1cm*2cm. The dressing was removed and the area was treated immediately with local disinfection with 2% chlorhexidine gluconate, the catheter fixation position was changed, the dressing was replaced with sterile gauze to cover the puncture site and surrounding skin, and fixed with an elastic bandage. On (b)(6) 2019, the skin itching symptoms were relieved and the blisters had been partially absorbed without bursting. The patient doesn't have any known allergies.
 
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Brand NameIV3000 1 HAND 10X12CM CTN 50
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
0447940038
MDR Report Key9482601
MDR Text Key171647311
Report Number8043484-2019-00920
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4008
Device Lot Number1827
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2019 Patient Sequence Number: 1
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