MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. INTRASITE GEL APPLIPAK 15G CTN 10; DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC

Model Number	66027311
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Impaired Healing (2378); Insufficient Information (4580)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that intrasite gel applipak 15g ctn 10 was used without a prescription on a punctured wound of a diabetic patient.This would have deteriorated the wound and led to the amputation of the leg.It is unknown what the current health status of patient is.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a definitive root cause.Probable causes may include incorrect application of device or incorrect skin preparation prior to use.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.A review of the batch manufacturing records could not be performed as no lot number was provided.However, there are no indications to suggest that the device did not meet specifications at the time of manufacture.The complaint history review confirms no previous complaints of this nature.A review of prior escalation actions found no actions applicable to the scope of this case.The risk files mitigate the reported issue with no updates required.Per complaint details, the product was used without a prescription on a punctured wound of a diabetic patient which ¿would have deteriorated the wound and led to the amputation of the leg¿.Details and/or verification of the patient outcome have not been provided as of the date of this medical investigation.Reportedly, no further information will be forthcoming.Without supporting medical documentation, the contributing clinical factors cannot be definitively concluded.The ifu /datasheet [7311] cautions use¿in deep, narrow-opening wounds (e.G., fistulas) and in body cavities where removal could be difficult.Patient impact beyond the reported use of the product in a puncture wound without a prescription could not be determined.Without clarification, it is unknown if the patient underwent amputation.The rationale for the procedure and/or a causal relationship cannot be concluded based on the reported ¿would have deteriorated the wound and led to the amputation of the leg¿.The patient¿s current health status remains unknown.No further medical assessment can be rendered at this time.This investigation is now complete with no further action deemed necessary at this stage.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Corrected data: h6 (health effect - clinical code, health effect - impact code).

• Brand Name: INTRASITE GEL APPLIPAK 15G CTN 10
• Common Device Name: DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC
• 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: 15656339
• Report Number: 8043484-2022-00191
• Device Sequence Number: 14085848
• Product Code: NAE
• UDI-Device Identifier: 00000050223480
• UDI-Public: 00000050223480
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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 Model Number: 66027311
• Device Catalogue Number: 7311
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 10/22/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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