MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE; TAPE AND BANDAGE, ADHESIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported that in a clinical observation of "use of negative-pressure wound dressings to prevent surgical site complications after primary hip arthroplasty: a pilot rct", that the pico negative pressure wound therapy + opsite (smith & nephew) was applied in 76 patients, 2 of these patient presented dehiscence.It is unknown treatment for this complication.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances related events of the reported events.The device was intended for use in treatment.As no samples were returned, a product evaluation could not be carried out.Dressings should be changed around every 3 days but in some cases may be left in place for 7 days.If the adhesive integrity is compromised due to prolonged wear, the surgical site may be susceptible to external contamination.¿ a clinical investigation concluded: the data provided is from an australian article, ¿use of negative-pressure wound dressings to prevent surgical site complications after primary hip arthroplasty: a pilot rct", with related documents under master complaint case-2020-00010110.The provided translation was presented in excel spreadsheet in english.Per subsequent e-mail it was noted, ¿no additional information is available.¿ without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the reported dehiscence and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.As the product code is unknown, a review of the device labelling could not be carried out.The associated risk file contains the reported event.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: OPSITE
• Type of Device: 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: 10262172
• MDR Text Key: 198489688
• Report Number: 8043484-2020-01943
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/12/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention