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 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, a 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

The device 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 event or determine a root cause.Probable root causes include application techniques and or a failed component, the ifu offers further guidance.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device no batch/lot number has been provided, therefore a review of the device history has not been possible.A complaint history review found other related failures.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.

• 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: 10262174
• MDR Text Key: 198482868
• Report Number: 8043484-2020-01946
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention