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 Unspecified Infection (1930)

Event Date 09/06/2011

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Luczak, b., ha, j., & gurfinkel, r.(2012).Effect of early and late mobilisation on split skin graft outcome.Australasian journal of dermatology, 53(1), 19-21.Doi: 10.1111/j.1440-0960.2011.00829.X.

Event Description

It was reported that in the literature review "effect of early and late mobilization on split skin graft outcome", (2) patients on the lm group experienced an infection after a split skin graft procedure in a lower extremity, where one layer of jelonet, a layer of foam secured with staples and crepe bandaging, was used postoperatively.It is unknown how or if adverse event was treated.The outcome of the patients is unknown.Further information is not available.

Manufacturer Narrative

It was reported that in the literature review "effect of early and late mobilization on split skin graft outcome", (2) patients on the lm group experienced an infection after a split skin graft procedure in a lower extremity, where one layer of jelonet, a layer of foam secured with staples and crepe bandaging, was used postoperatively.It is unknown how or if adverse event was treated.The outcome of the patients is unknown.Further information is not available.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.As no clinical information has been received (despite being requested), no clinical factors could be concluded to have contributed to the event(s).Furthermore, patient outcome(s) could not be determined.No further assessment was possible based on the information currently available.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.The investigation is now complete; 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: 15664146
• MDR Text Key: 302327118
• Report Number: 8043484-2022-00194
• 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: 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: 03/06/2023
• Supplement Dates FDA Received: 03/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention