MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ACTICOAT FLEX 7 10X12.5CM CTN 5; DRESSING, WOUND, DRUG

Catalog Number	66800397
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, an acticoat flex 7 10x12.5cm ctn 5 was cut into a strip and used for tunneling of wound as a packing material.When the wound was x-rayed to confirm packing material was removed, the amount of acticoat documented in the wound did not show on x ray.Therefore they had to order a ct scan to confirm it was still in place.It showed up on ct scan but not an x ray.Patient required surgery to remove dressing.
Additional Manufacturer Narrative
Internal reference number (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device was not returned for evaluation.The clinical/medical investigation concluded that, in the absence of the requested medical documentation, clinical factors which could have contributed to the reported adverse event could not be definitively determined.Nor does this case defer to a deficiency or an association with the reported adverse event and the s+n acticoat flex 7.According to the report, a computed tomography scan (not provided) confirmed the packing was still in place and surgery was required for its removal.It was reported the patient¿s wound had a kci wound vac applied to it and within two days the wound closed and covered the acticoat tail.The impact to the patient was the retained acticoat flex 7 strip, and the reported surgical procedure.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.Device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 15 months did not reveal similar events for the device listed.A review of the instructions for use documents for acticoat flex 7 provides complete guidelines of indications, contraindications and precautions that may occur during the use of silver-coated antimicrobial barrier dressing.A review of the risk management file revealed this adverse event was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior escalated actions related to this part number and failure mode.With the results of this investigation the root cause of this event could not be determined.A factor that could contribute to the reported event include treatment technique error.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.

• Brand Name: ACTICOAT FLEX 7 10X12.5CM CTN 5
• Common Device Name: DRESSING, WOUND, DRUG
• 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: 18049665
• Report Number: 8043484-2023-00081
• Device Sequence Number: 7468313
• Product Code: FRO
• UDI-Device Identifier: 00040565124339
• UDI-Public: 00040565124339
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 66800397
• 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: 08/12/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown