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

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

Patient Problem Purulent Discharge (1812)

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 purulent wound.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

H3, h6: the devices used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported events or determine a root cause.Probable cause includes, dressing left on longer than prescribed or inherent risk of procedure.Medical review concluded, the root cause of the reported purulent wound 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.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch/lot number has been provided, therefore a review of the device history has not been possible, complaint history review found other related events this investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.(b)(4).

• Brand Name: PRIMAPORE
• 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: 10262160
• MDR Text Key: 198489059
• Report Number: 8043484-2020-01937
• 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: 03/08/2021

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: 03/05/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention