MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 55X45CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Model Number	4989
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment the sterile pouch of a opsite incise 55x45cm ctn 10 opened easily and with small strength than usual.The opsite incise 55x45cm ctn 10 was not used for treatment because it was in question the sealing integrity of the pouch.The treatment was completed without delay and it is unknown how the treatment was resume.No patient injuries or other complications were reported.
Additional Manufacturer Narrative
H3, h6: we have now concluded our investigation into the complaint reported.The device intended to use in treatment has been returned and evaluated.Visual inspection found no defects.Functional evaluation was performed.The evaluation followed the incise drapes in-process control procedure and passed test.The reported problem was not confirmed, we have not been able to establish a relationship between the device and the reported event or determine a root cause.Factors that can contribute to the reported event include user feel issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file does not contain further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE INCISE 55X45CM CTN 10
• 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: 11828746
• Report Number: 8043484-2021-01140
• Device Sequence Number: 3722009
• Product Code: KGX
• UDI-Device Identifier: 05000223415525
• UDI-Public: 05000223415525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 11/01/2025
• Device Model Number: 4989
• Device Catalogue Number: 4989
• Device Lot Number: 202045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1