MAUDE Adverse Event Report: SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. CVS HEALTH; NON-STICK PADS

Model Number	UPC#050428307274
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 10/01/2024, the manufacturer has not finished their investigation.Aso reviewed records of biocompatibility tests, and no issues were noted.Refer to section b.6 of this report for further details.
Event or Problem Description
On the initial report on 09/04/2024, the consumer stated that she used the product on a cut on her arms.She went to the doctor on (b)(6).They washed the pad with sterile water, as the pad was stuck to the wound, causing it to bleed.The doctor recommended not using the product again.
Event or Problem Description
On the initial report on 09/04/2024, the consumer stated that she used the product on a cut on her arms.She went to the doctor on (b)(6).They washed the pad with sterile water, as the pad was stuck to the wound, causing it to bleed.The doctor recommended not using the product again.On the completed cir received from the consumer on 09/30/2024, the consumer stated that the product was stuck to her injury.She required treatment from a doctor because the product kept sticking to the injury and caused bleeding when she tried to take it off.
Additional Manufacturer Narrative
As of 10/28/2024, no lot or returned product were provided therefore manufacturer is unable to perform an investigation.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report on (b)(6) 2024, the consumer stated that she used the product on a cut on her arms.She went to the doctor on july 04.They washed the pad with sterile water, as the pad was stuck to the wound, causing it to bleed.The doctor recommended not using the product again.On the completed cir received from the consumer on 09/30/2024, the consumer stated that the product was stuck to her injury.She required treatment from a doctor because the product kept sticking to the injury and caused bleeding when she tried to take it off.
Additional Manufacturer Narrative
As of 10/28/2024 no lot or returned product were provided therefore manufacturer is unable to perform an investigation.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.As of 12/16/2024 the lab report was received for returned product.The absorbency results on the samples were within range of specification m-242, rev.02.The c of a is reviewed with every shipment of pad to ensure it meets specification requirements.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report on (b)(6) 2024, the consumer stated that she used the product on a cut on her arms.She went to the doctor on july 04.They washed the pad with sterile water, as the pad was stuck to the wound, causing it to bleed.The doctor recommended not using the product again.On the completed cir received from the consumer on (b)(6) 2024, the consumer stated that the product was stuck to her injury.She required treatment from a doctor because the product kept sticking to the injury and caused bleeding when she tried to take it off.
Additional Manufacturer Narrative
As of 10/28/2024 no lot or returned product were provided therefore manufacturer is unable to perform an investigation.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.The following sections were updated: b5, b6, and g6.As of 12/16/2024 the lab report was received for returned product.The absorbency results on the samples were within range of specification m-242, rev.02.The c of a is reviewed with every shipment of pad to ensure it meets specification requirements.The following sections were updated: b6, d4,g6,h4,h6.As of 12/23/2024 manufacturer evaluated retained samples of the same lot reported with no defects noted.The following sections were updated: b6, g6, h3 and h6.Udi notes: the expiry date is not present on the device label.

• Brand Name: CVS HEALTH
• Common Device Name: NON-STICK PADS
• Manufacturer (Section D): SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO.; no.18, zhihe dong road; suzhou industrial park; suzhou, 21512 2; CH 215122
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd; sarasota, FL 34204
• MDR Report Key: 20346382
• Report Number: 1038758-2024-00026
• Device Sequence Number: 8000230
• Product Code: NAC
• UDI-Device Identifier: 00050428307274
• UDI-Public: 00050428307274
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/26/2024

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 Expiration Date: 09/28/2024
• Device Model Number: UPC#050428307274
• Device Catalogue Number: 935683
• Device Lot Number: 2384-20230311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/04/2024; 09/04/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/29/2024; 12/17/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female