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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN STERILE 20X10CM CTN 100 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. MELOLIN STERILE 20X10CM CTN 100 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66974939
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, during wound treatment, there was a brown foreign substance under the film of the wound-contact side of the dressing of a melolin sterile 20x10cm ctn 100. This happened before use in patient. Treatment was performed, without any delay, with a back-up device instead. Patient was not harmed as consequence of this problem.
 
Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation. The visual evaluation confirms a brown foreign substance under the film of the wound-contact side of the dressing, establishing a relationship between the device and the reported event. The root cause was identified as a manufacturing process issue. The manufacturing records show no evidence that the product did not meet specification at the time of manufacture. The complaint history file contains further instances. This investigation is now complete with no further action deemed necessary at this stage. Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
 
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Brand NameMELOLIN STERILE 20X10CM CTN 100
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12442927
MDR Text Key270584514
Report Number8043484-2021-01749
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66974939
Device Lot Number2102B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2021
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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