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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASO LLC EQUATE; FAST-HEALING HYDROCOLLOID GEL PAD BANDAGES
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ASO LLC EQUATE; FAST-HEALING HYDROCOLLOID GEL PAD BANDAGES Back to Search Results
Model Number UPC#194346050062
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Tears (2516)
Event Date 03/26/2024
Event Type  Injury  
Event Description
On the initial report received by aso on 02/21/2024, the consumer stated that the product didn't fall off as it said, and she went to the doctor.The consumer stated that it was stinky and infected.The customer states she used a special ointment prescribed by the doctor.On the completed cir received from the consumer on 03/05/2024, the consumer states that after 8 days, the product is still on her wound.The doctor removed the bandage, but the wound was infected.
 
Manufacturer Narrative
As of 03/18/2024 returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b.6 of this report for further details.
 
Event Description
On the initial report received by aso on 02/21/2024, the consumer stated that the product didn't fall off as it said, and she went to the doctor.The consumer stated that it was stinky and infected.The customer states she used a special ointment prescribed by the doctor.On the completed cir received from the consumer on 03/05/2024, the consumer states that after 8 days, the product is still on her wound.The doctor removed the bandage, but the wound was infected.
 
Manufacturer Narrative
As of 03/18/2024 returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b.6 of this report for further details.As of 04/15/2024 manufacturer has completed their investigation with no issues found.Please refere to b6 for details.
 
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Brand Name
EQUATE
Type of Device
FAST-HEALING HYDROCOLLOID GEL PAD 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
aso complaints
300 sarasota center blvd.
MDR Report Key18955660
MDR Text Key338305509
Report Number1038758-2024-00005
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberUPC#194346050062
Device Catalogue Number658302662
Device Lot Number00007289
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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