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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 6.5X5CM CTN 100; DRESSING,WOUND,OCCLUSIVE
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SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 6.5X5CM CTN 100; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66000708
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2020
Event Type  malfunction  
Event Description
It was reported that the film around the compress does not stick.It is unknown if there was a patient involved and a backup available to complete the treatment.
 
Manufacturer Narrative
H3, h6: the device used in treatment has been returned and evaluated, establishing a relationship between the device and the reported event.The visual inspection confirmed that the dressing lacked adhesive.The root cause has been determined as a manufacturing issue.The bulk roll used to manufacture these dressings are produced with areas marked up to highlight low adhesive levels.On this occasion it appears that this particular area had not been highlighted.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 of the reported 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
OPSITE POST OP 6.5X5CM CTN 100
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key10197649
MDR Text Key196584525
Report Number8043484-2020-00972
Device Sequence Number1
Product Code NAD
UDI-Device Identifier04582111150899
UDI-Public4582111150899
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66000708
Device Lot Number201946
Date Manufacturer Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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