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 Impaired Healing (2378)

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", (7) patients (5 on em group and 2 in lm) had graft loss and non-healing wound 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 events were 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", (7) patients (5 on em group and 2 in lm) had graft loss and non-healing wound 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 post-operatively.It is unknown how or if adverse events were treated.The outcome of the patients is unknown.Further information is not available.The device was not returned/available 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.There is no evidence to suggest a device deficiency, or that the device has failed to meet specifications at the time of manufacture.A complaint history review (chr) revealed a small number of similar instances in the last 12 months.A clinical evaluation was conducted and the following observation(s) made: correspondence revealed ¿the product was simply a standard dressing used¿ and there was no independent assessment of the smith & nephew product and/or outcomes, nor was the smith & nephew product reported as a separate variable.The article reported, ¿no specific statistically significant cause was identified for these cases¿ in regards to the graft non-healing in both groups.As of the date of this medical investigation, the requested clinical documentation has not been received.Without the requested medical documentation, no clinical factors could be concluded to have contributed to the event.The patient outcome beyond that which was reported in the article could not be determined.No further medical assessment can be rendered at this time.A risk management review (rmr) was conducted.With no clear failure outlined within the complaint description to determine the associated hazard, a review of rmr 13-01 confirmed ¿delayed wound healing¿ (non-healing wound) is captured as a foreseeable harm against numerous potential failures, with a residual risk rating of ¿low¿.A recent review of complaints for jelonet between 1st january 2018 to 1st october 2022 confirms that no complaints associated with the harm delayed wound healing were recorded.¿skin graft failure, re-graft required¿ (graft loss) is currently not detailed in rmr 13-01.Given the limited information, the hazard and/or sequence of events that lead to this harm could not be determined, therefore, a review of current hazards to identify when graft loss may be foreseeable, will be performed.As the specific device involved has not been identified within the complaint detail, a targeted review of labelling/product ifu cannot be carried out.A review revealed no escalations relating to 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 or that it was applied incorrectly.In the absence of the device for analysis and/or further information as to the circumstances, including additional clinical information, a more specific hypothesis as to the cause cannot be offered at this time.Enquiries into this matter are now complete and 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: 15664103
• MDR Text Key: 302327522
• Report Number: 8043484-2022-00193
• 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: 06/01/2023

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: 05/30/2023
• Supplement Dates FDA Received: 06/01/2023
• 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): Required Intervention