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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE LIFE M 12.9X12.9 CTN10 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. HYDROSITE LIFE M 12.9X12.9 CTN10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66391068
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Event Description
It was reported that, when the release film was removed from the hydrosite life m 12. 9x12. 9 ctn10, about a half silicone adhesive was removed and did not remain on the dressing, so it could not be used. A smith and nephew back up device was available.
 
Manufacturer Narrative
The devices, used in treatment, the carrier has been received for evaluation, establishing a relationship between the device and the reported event. A visual inspection confirmed silicone remained on the carrier, with the root cause, identified as a raw material 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 of the reported events. 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 NameHYDROSITE LIFE M 12.9X12.9 CTN10
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 Key12005671
MDR Text Key256454339
Report Number8043484-2021-01488
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 foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66391068
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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