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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA MESHED BILAYER WOUND MATRIX SIZE 2X2; N/A
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INTEGRA LIFESCIENCES CORPORATION INTEGRA MESHED BILAYER WOUND MATRIX SIZE 2X2; N/A Back to Search Results
Catalog Number MWM2021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported the meshed bilayer wound matrix was applied in a patient with an exposed tendon and after three weeks the tendon was still exposed.No additional information has been provided.
 
Manufacturer Narrative
The integra meshed was not returned for evaluation (as per customer, product not available), therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
Event Description
N/a.
 
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Brand Name
INTEGRA MESHED BILAYER WOUND MATRIX SIZE 2X2
Type of Device
N/A
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
105 morgan lane
105 morgan lane
plainsboro NJ 08536
MDR Report Key10820025
MDR Text Key216671287
Report Number1121308-2020-00068
Device Sequence Number1
Product Code KGN
Combination Product (y/n)N
PMA/PMN Number
K081635
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMWM2021
Device Lot Number3899822
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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