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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN THIN 10X10CM CTN 5 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN THIN 10X10CM CTN 5 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 66047578
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the package of allevyn thin was found open when it was going to be used to fix the catheter. Back up device was available. No harm to the patient reported.
 
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Brand NameALLEVYN THIN 10X10CM CTN 5
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 Key13656155
MDR Text Key286494973
Report Number8043484-2022-00086
Device Sequence Number1
Product Code NAD
UDI-Device Identifier05000223452919
UDI-Public05000223452919
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number66047578
Device Catalogue Number66047578
Device Lot Number2023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2020
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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