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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 4007
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2019
Event Type  malfunction  
Manufacturer Narrative
We have now concluded our investigation for the complaint received. A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant. In addition it can be confirmed that all finished product specification testing was satisfied at the point of release. A complaints history review was carried out using the lot and part numbers provided, there have been further complaints reported with this issue in the past four years. It was reported that the product was used for treatment in which the dressings were found to have low adhesion. As no samples were returned, a functional evaluation was not possible. Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing. There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification. There are also regular tests carried out to monitor the finished product. We have not been able to identify a definitive root cause on this occasion or confirm a relationship between the event and the device. No further actions by smith and nephew are deemed necessary at this stage. However, we will continue to monitor for any adverse trends relating to this product range. Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
 
Event Description
It was reported that following a cannula insertion when using dressings for fixation, it was found that the adhesive was poor. After replacement, it was used normally without causing no adverse consequences to patients. It is unknown if there was any delay.
 
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Brand NameIV3000 1 HAND 6X7CM CTN 100
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 Key9712408
MDR Text Key181664578
Report Number8043484-2020-00099
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
Type of Report Initial
Report Date 02/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4007
Device Lot Number1835
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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