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

Catalog Number UNKNOWN

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

Patient Problem Bacterial Infection (1735)

Event Date 09/01/1980

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Brady, s.C., snelling, c.F., & chow, g.(1980).Comparison of donor site dressings.Annals of plastic surgery, 5(3), 238-243.Doi: 10.1097/00000637-198009000-00013.

Event Description

It was reported that, on the literature review ""comparison of donor site dressings"", a total of sixty four (64) donor sites were treated with a jelonet dressing to improve the wound healing process.From this cohort, three (3) donor sites were tested positive for bacterial infections: one (1) with s.Aureus, one (1) with pseudomonas aeruginosa and one (1) with staphylococcus aureus.Any specific measures taken to resolve all three infections were not listed within the publication.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

It was reported that, on the literature review ""comparison of donor site dressings"", a total of sixty four (64) donor sites were treated with a jelonet dressing to improve the wound healing process.From this cohort, three (3) donor sites were tested positive for bacterial infections: one (1) with s.Aureus, one (1) with pseudomonas aeruginosa and one (1) with staphylococcus aureus.Any specific measures taken to resolve all three infections were not listed within the publication.The outcome of the patients is unknown.No further information is available.It is worthy of note that this complaint relates to an article written circa 1980.The device was not returned for analysis.We have therefore not been able to confirm a relationship between the event and the device, or identify a definitive root cause.A lot number for the device was not provided, therefore it was not possible to carry out a device history review.A complaint history review for the product family revealed a small number of similar instances in the last 12 months.A clinical evaluation was conducted.This concluded that no clinical factors were found which would have contributed to the infections.The impact to the patient beyond that which has already been documented in the article could not be confirmed nor concluded based on the information provided; therefore, no further medical assessment was warranted.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.As the specific device involved has not been identified within the complaint detail, a targeted review of labeling/product ifu cannot be carried out.A review concluded that there are no prior escalated actions related to this product and the reported event.A probable root cause for this complaint cannot be determined; there is no definitive link between the device and the adverse event.Possible causes could be that the dressing was not appropriate for the wound, that it was applied incorrectly or that there was inadequate preparation of the wound site before application.No further actions by smith & nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith & nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: JELONET
• 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: 15664159
• MDR Text Key: 302327472
• Report Number: 8043484-2022-00195
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/06/2023
• 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): Other