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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE 10X20CM CTN 75; DRESSING, WOUND, OCCLUSIVE
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SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE 10X20CM CTN 75; DRESSING, WOUND, OCCLUSIVE Back to Search Results
Catalog Number 66974943
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Event Description
It was reported that before use, one melolin non sterile 10x20cm ctn 75 was found to have a hair-like foreign substance.No patient involved.
 
Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection reported a hair-like foreign substance attached to the cotton layer of the dressing, establishing a relationship between the device and the reported event.The root cause was identified as a manufacturing process issue.No lot/serial number has been provided; therefore, a review of the device history is not possible.A complaint history review found no other related event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
 
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Brand Name
MELOLIN NON STERILE 10X20CM CTN 75
Type of Device
DRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK  HU3 2BN
MDR Report Key12242881
MDR Text Key264256305
Report Number8043484-2021-01649
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66974943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received07/28/2021
Supplement Dates Manufacturer Received08/05/2021
Supplement Dates FDA Received08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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