MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ACTICOAT 40X40CM CTN 6; DRESSING, WOUND AND BURN, OCCLUSIVE

Catalog Number	66000794
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Erosion (2075); Impaired Healing (2378)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
It was reported that, following upper body burns caused by hot oil, the patient was treated with acticoat 40x40cm ctn 6, which caused pseudo-eschar to form on the burn site.Treatment was prescribed as a classic three-day course involving moistening with water (either water-soaked gauze, intrasite conformable material or hypafix and moistening three times a day), as well as wound debridement or autolytic debridement to clean up, however, the issue became worse with the product.It is unclear what the patient's current health status is and how the treatment was finished.
Event or Problem Description
It was reported that, following upper body burns caused by hot oil, the patient was treated with acticoat 40x40cm ctn 6, which caused pseudo-eschar to form on the burn site.Treatment was prescribed as a classic three-day course involving moistening with water (either water-soaked gauze, intrasite conformable material or hypafix and moistening three times a day), as well as wound debridement that consisted of scrubs with chlorhexidine and cetrimide in the ot to clean up, however, the issue became worse with the product.The site was cleaned with normal saline or granudacyn at each dressing change, the patient did not attend ot for a second scrub.The wound was exuding moderately and his acticoat was also being wet 3 times a day, also, compression was utilized the patient was fitted with a tubivest.It is unclear what the patient's current health status is and how the treatment was finished.
Additional Manufacturer Narrative
H3, h6: no product was returned for this case.A documentation review was performed.Manufacturing records could not be performed, no product identifier was provided.Complaint history records details a small number of cases of this nature, with no open or closed escalations within the scope of this report.The instruction for use "ifu" the ifu provides adequate instruction on the safe operation and use of this product, and there are no contributory factors contained within.The risk management documentation for acticoat has been reviewed, to assess whether the alleged failure and associated foreseeable harms have been anticipated, no updates are required.The file contains ¿delayed wound healing¿ as a foreseeable harm.Medical review concluded.Based on the documentation provided, definitive clinical factors have not been concluded to have contributed to the reported event.It cannot be confirmed that the ifu was consistently adhered to and its unknown if initial cleanser during ot debridement could have been a contributing factor.Patient (#2) impact included the reported pseudo-eschar formation within the first 3 days of dressing use, then exchanged to competitor products, and reportedly experienced delayed healing.It is unclear if the reported delayed healing was due to the reported conservative treatment with competitor products; however, no infection was reported due to the initial use of the acticoat dressing; therefore, the dressing appears to have functioned as an antimicrobial barrier as intended.The current patient status is unknown, although the patient was ¿redressed¿ with a competitor product ¿until healed¿ and discharged 29-jun-2023.Further patient impact could not be determined.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: ACTICOAT 40X40CM CTN 6
• Common Device Name: DRESSING, WOUND AND BURN, OCCLUSIVE
• 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: 18049508
• Report Number: 8043484-2023-00079
• Device Sequence Number: 7499585
• Product Code: MGP
• UDI-Device Identifier: 05000223449858
• UDI-Public: 05000223449858
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K992221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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 Catalogue Number: 66000794
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown