MAUDE Adverse Event Report: ASO LLC UP&UP; FLEXIBLE FABRIC BANDAGES

Model Number UPC#017276226256

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Skin Inflammation/ Irritation (4545)

Event Date 10/24/2021

Event Type  Injury  

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on (b)(6) 2021 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 11/08/2021 aso has no received returned samples from consumer or lot info.However, aso reviewed records of biocompatibility tests and latex screening with no issues noted.

Event Description

On the initial report received by aso on 10/08/2021 consumer informed that upon removal of the bandage she noticed scars and torn skin that she believes are caused by the adhesive in the product.She added believes the adhesive caused her an allergic reaction or was too strong.On completed cir received on (b)(6) 2021, consumer added she felt pain while wearing the bandage and decided to remove, then upon removal she stated the product pulled off her skin and also left welts.Consumer sought medical attention.

• Brand Name: UP&UP
• Type of Device: FLEXIBLE FABRIC 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 12838217
• MDR Text Key: 285767384
• Report Number: 1038758-2021-00034
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#017276226256
• Device Catalogue Number: 245070727
• Date Manufacturer Received: 10/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female