MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 15.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000712
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the opsite dressing had a foreign body stuck to the product.After pasting the dressing on the patient skin the nurse identified that the foreign body was a mosquito.Customer choose to continue using the product.The mosquito was stuck between cotton and plastic.No adverse events or injuries have been reported as a result.

• Brand Name: OPSITE POST OP 15.5X8.5CM CTN 20
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10610261
• Report Number: 8043484-2020-03071
• Device Sequence Number: 2941380
• Product Code: KGX
• UDI-Device Identifier: 05000223441333
• UDI-Public: 05000223441333
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66000712
• Device Lot Number: 201945
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1