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

Catalog Number UNKNOWN

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

Patient Problem Sepsis (2067)

Event Type  Injury  

Event Description

It was reported that in a study that was investigating the relationship between surgical wound bacterial colonization and the development of surgical wound infection after lower limb vascular surgery, opsite-post-op dressings (smith & nephew medical, hull, uk) were used to cover the surgical wounds in all patients.It is stated that one of the patients developed sepsis.

Manufacturer Narrative

H10.H3, h6: the device, used in treatment, has not been returned for evaluation.Visual inspection and functional evaluation could not be performed.We have been unable to confirm a relationship between the event and the device or identify a root cause on this occasion.If the device is returned in the future this complaint will be re-assessed.A clinical review has taken place, however without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Device history record review could not be performed as no part number/lot number was provided, however, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported event has been reviewed, revealing further instances which are being monitored to determine if additional actions are required.A risk management review has taken place, opsite file contains multiple failure modes which can lead to local infection.These include dressing left on too long, poor adhesion of dressing and poor absorption of the dressing.Without further information the exact failure modes involved cannot be identified.The ifu has been reviewed, which contain adequate cautions and warnings with regards to the use and limitations.This investigation is now complete with no further action deemed necessary and at this time.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKNOWN OPSITE POST-OP
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9896224
• MDR Text Key: 185727000
• Report Number: 8043484-2020-00233
• 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: 07/21/2020

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/29/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other