MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. CUTICERIN; DRESSING, WOUND, DRUG

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Impaired Healing (2378); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from an electronic data collection that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, as part of a retrospective data collection activity conducted from an electronic medical record in united states, one (1) patient presented an increase in redness with extreme itching, pain and an apparent increase in the size of the wound after treating an unspecified wound with a cuticerin dressing.The surgeon had a look at the wound and recommended the administration of avelox.Additional details such as occurrence dates, onset for the reported symptoms and patient specific information are not available.As this data collection has been done retrospectively, it is impossible to identify the individual health care professionals responsible for managing each wound treatment to revisit each adverse event.As such, no further information will be available.
Additional Manufacturer Narrative
The product was not returned for evaluation.A documentation review was performed.A review of the batch records could not be completed, no identifiable sku or product identifier has been provided to conduct the review.Complaint history has revealed similar case, during the period reviewed.There are no open nor closed escalation actions within the scope of this investigation.Non are considered.The risk management documentation for cuticerin has been reviewed to assess whether the alleged failure and associated harms have been anticipated.Type 4 sensitisation reaction¿, ¿irritation/irritant contact dermatitis¿ and ¿pain¿ are captured as foreseeable harms against numerous potential failures, with a residual risk rating of ¿low¿ and ¿wound deterioration¿ is captured as foreseeable harms against numerous potential failures, with a residual risk rating of ¿med and is in keeping with the risk file, deemed acceptable.The probable cause remains unknown.Product instructions for the cuticerin family have been reviewed, contributory factors may include sensitivity to product ingredients.Also time left on wound, product may be left on for a period of two weeks.Medical review concluded, the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Therefore, the clinical root cause and/or patient outcome beyond that which was documented in the retrospective data collections could not be confirmed nor concluded; since no further medical information will be provided, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: CUTICERIN
• 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: 15763883
• Report Number: 8043484-2022-00199
• Device Sequence Number: 6126606
• Product Code: FRO
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown