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

Catalog Number UNKN05004802

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

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2008

Event Type  Injury  

Event Description

It was reported that on literature review "efficacy of new multimodal preventive measures for post-operative deep sternal wound infection", 1 patient who underwent a cardiovascular surgery, and that was later treated with a combination of an unspecified highly absorbent pad and an opsite post-op film.Experienced a deep sternal wound infection.The specific pathogenic bacterial species isolated from this patient are unknown, although the authors report their findings in regards of the incidence of each bacterial strain on the whole study group: (b)(6) (38.5%); (b)(6) (30.8%); (b)(6) (11.5%), (b)(6) (3.8%), pseudomonas aeruginosa (3.8%), stenotrophomonas maltophilia (3.8%) and corynebacterium species (3.8%).Details related to the specific measures taken to treat this adverse event, as well as the final outcome of the patient are unknown at this time.No further information is available at this time.

Manufacturer Narrative

Internal complaint reference:(b)(4).

Manufacturer Narrative

It was reported that on literature review "efficacy of new multimodal preventive measures for post-operative deep sternal wound infection", 1 patient who underwent a cardiovascular surgery, and that was later treated with a combination of an unspecified highly absorbent pad and an opsite post-op film.Experienced a deep sternal wound infection.The specific pathogenic bacterial species isolated from this patient are unknown, although the authors report their findings in regards of the incidence of each bacterial strain on the whole study group: mrsa (38.5%); methicillin- resistant staphylococcus capitis (30.8%); methicillin-resistant staphylococcus epidermidis (11.5%), methicillin-susceptive staphylococcus aureus (3.8%), pseudomonas aeruginosa (3.8%), stenotrophomonas maltophilia (3.8%) and corynebacterium species (3.8%).Details related to the specific measures taken to treat this adverse event, as well as the the final outcome of the patient are unknown at this time.No further information is available at this time.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.As no lot number was provided it was not possible to carry out a device history review a complaint history review revealed no similar instances in the last three years.A risk management review concluded that the sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.A clinical review concluded that without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.It is noted, an unknown ¿applied dressing material with a highly absorbent pad¿ was used, which can¿t be ruled out as a possible contributing factor.The 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.Probable root causes include incorrect wound preparation, infrequent dressings or the event has been caused by the unknown dressing material.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct skin and wound preparation and frequency of dressing changes.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN OPSITE POST OP
• 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: 13636307
• MDR Text Key: 286561332
• Report Number: 8043484-2022-00083
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention