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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE EXUFIBER; DRESSING, WOUND
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MOLNLYCKE HEALTH CARE EXUFIBER; DRESSING, WOUND Back to Search Results
Model Number 603308
Device Problem Material Disintegration (1177)
Patient Problems Fever (1858); Inflammation (1932); Post Traumatic Wound Infection (2447)
Event Date 11/08/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturer investigation is in progress.
 
Event Description
Exufiber ribbon was deeply inserted as a cavity filler in a deeply undermined diabetic foot ulcer (dfu) on right foot.Dressing residue remained in wound post removal.An infection requiring antibiotic treatment was diagnosed immediately after.Follow up information received 15nov2018 indicates the dressing was removed as much as possible and that the patient experienced fever and inflammation of the dfu.Follow up information received 28nov2018 indicates the patient was hospitalized for wound debridement.Request has been made for additional information, however no additional information is available at the time of this report.
 
Manufacturer Narrative
Manufacturer investigation completed 13dec2018.
 
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Brand Name
EXUFIBER
Type of Device
DRESSING, WOUND
Manufacturer (Section D)
MOLNLYCKE HEALTH CARE
5550 peachtree parkway
suite 500
norcross GA 30092
MDR Report Key8160419
MDR Text Key130212871
Report Number3004763499-2018-00007
Device Sequence Number1
Product Code NAC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/28/2021
Device Model Number603308
Device Lot Number18061967
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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