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, 5 patients developed an unspecified deep wound infection (involving muscle, bone and/or mediastinum), within a time range of 1 to 5 postoperative days.In conjunction with this adverse event, one of the following interventions were conducted: excision of wound tissue, a positive wound culture finding or treatment with antibiotics, although it was not specified which one was conducted for each patient/adverse event within the study.

Manufacturer Narrative

H3, h6: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12561936
• MDR Text Key: 274253592
• Report Number: 8043484-2021-01798
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other