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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. CADEX DRESSING 10X5G; TAPE AND BANDAGE, ADHESIVE
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SMITH & NEPHEW MEDICAL LTD. CADEX DRESSING 10X5G; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 66800053
Device Problems Problem with Sterilization (1596); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when a pouch was taken out the carton, it was confirmed the pouch was torn and the ointment was leaking from the poorly sealed part because part of this pouch was not sealed.No harm or injury reported.
 
Manufacturer Narrative
We have now concluded our investigation into this report.The product intended for use in treatment, was received and evaluated.The supplied images have also been reviewed establishing a relationship between the reported event.The pouch was not fully sealed, stained and contents dry.The root cause has been determined as operator error.The manufacturing records show no evidence that the product did not meet the specification upon release.Complaint history found no related events, 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
CADEX DRESSING 10X5G
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK  HU3 2BN
MDR Report Key11100655
MDR Text Key224541737
Report Number8043484-2020-04416
Device Sequence Number1
Product Code KGX
UDI-Device Identifier04987777000067
UDI-Public4987777000067
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800053
Device Lot NumberCDA142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Date Manufacturer Received04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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