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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE S 10.3X10.3 CTN10 DRESSING, WOUND, OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE S 10.3X10.3 CTN10 DRESSING, WOUND, OCCLUSIVE Back to Search Results
Model Number 66801067
Device Problems Contamination (1120); Unexpected Color (4055)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
It was reported that an allevyn life s 10. 3x10. 3 ctn10 was found to have brown color/dark spots on it. No patient involved.
 
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Brand NameALLEVYN LIFE S 10.3X10.3 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 Key12332549
MDR Text Key266929993
Report Number8043484-2021-01687
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2021
Device Model Number66801067
Device Catalogue Number66801067
Device Lot Number1844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2018
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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