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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASO LLC CVS; ADHESVE BANDAGES
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ASO LLC CVS; ADHESVE BANDAGES Back to Search Results
Model Number UPC50428462768
Device Problem Failure to Obtain Sample (2533)
Patient Problem Skin Tears (2516)
Event Date 10/21/2015
Event Type  Injury  
Manufacturer Narrative
11/19/2015 to date, end user has not provided samples or provided a lot number to assist the investigation.Customer has been contacted three different times.Representative samples from the same type product have been evaluated for biocompatibility.
 
Event Description
(b)(6) 2015 - the user reported that the product adhered to the wound site resulting in pulling skin off and causing bleeding upon removal.
 
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Brand Name
CVS
Type of Device
ADHESVE BANDAGES
Manufacturer (Section D)
ASO LLC
300 sarasota center blvd.
sarasota FL 34240
Manufacturer (Section G)
ASO LLC
300 sarasota center blvd.
sarasota FL 34240
Manufacturer Contact
steve walter
300 sarasota center blvd.
sarasota, FL 34240
9413790300
MDR Report Key5240389
MDR Text Key31764700
Report Number1038758-2015-00098
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 10/22/2015,10/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUPC50428462768
Device Catalogue NumberSKU935686
Was Device Available for Evaluation? No
Distributor Facility Aware Date10/21/2015
Date Report to Manufacturer10/22/2015
Initial Date Manufacturer Received 10/21/2015
Initial Date FDA Received11/20/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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