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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE ROLL 50CMX7M CTN 1 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE ROLL 50CMX7M CTN 1 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66974930
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Event Description
It was reported that, before use, it was confirmed there were a lot of foreign substance inside the cotton layer of the roll. Please confirm the attached photo of the sample. A backup was available. No delay was reported. No patient harm was reported.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameMELOLIN NON STERILE ROLL 50CMX7M CTN 1
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 Key13047841
MDR Text Key284632991
Report Number8043484-2021-02028
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66974930
Device Lot Number2127B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received02/22/2022
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

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