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

Catalog Number UNKN05005100

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/01/2004

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Wynne, r., botti, m., stedman, h., holsworth, l., harinos, m., flavell, o., & manterfield, c.(2004).Effect of three wound dressings on infection, healing comfort, and cost in patients with sternotomy wounds: a randomized trial.Chest, 125(1), 43-49.Doi: 10.1378/chest.125.1.43.

Event Description

On the literature article named "effect of three wound dressings on infection, healing comfort and cost in patients with sternotomy wounds: a randomized trial", the authors of the study reported that, when using a primapore dressing to treat postoperative patients with sternotomy wounds, 1 patient developed an unspecified superficial sternal wound infection (involving skin and subcutaneous tissues), within a time range of 1 to 5 postoperative days.The infection was treated with antibiotics, and resolved by follow up.Since this data was collected from an online anonymized publication, further details on the patient's outcome are unknown.

Manufacturer Narrative

The device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root cause may include, wound criteria and after care.Medical review concluded, 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 review is not required.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.No lot/serial number has been provided; therefore, a review of the device history is not possible, complaint history review found further instances of the reported event.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: UNKN 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: 12561932
• MDR Text Key: 274253814
• Report Number: 8043484-2021-01794
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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
• Device Catalogue Number: UNKN05005100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other