MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4628
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, according to the hospital report on (b)(6) 2024 at 16:00 the nurse in the infusion found the child's elbow around the indwelling needle skin had visible red rash, part of the fusion, protruding from the skin.The indwelling needle was punctured on 14-sept.Nurse immediately removed the needle patch opsite flexigrid 6x7cm and sterilized the skin, then replaced the film after it dried.Nurse told the doctor on duty to continue to observe the skin rash situation and strictly hand over to the nurse.At 20:00, the nurse on the night shift, found that small red herpes appeared on the skin at the place of the indwelling needle patch and immediately removed the needle patch and sterilized the skin.The following morning, dermatology consultation was requested; a large number of erythematous spots and papules were seen on the left elbow.Diagnosis: dermatitis, wet compress with sodium chloride injection three times a day; topical application of dinaid cream twice a day; topical application of fusidic acid cream twice a day.Treatment plan: the child appeared left elbow skin rash, combined with the dermatology consultation, additional diagnosis: dermatitis, to be saline wet compresses, dinaid cream, fusidic acid cream topical.The child appeared rash can not be excepted side effects of doxycycline, stop using erythromycin anti-mycoplasma treatment.Medical advice: avoid light, pay attention to local rash care.How the treatment finished and the child's health status is unknown.
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates 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.
Additional Manufacturer Narrative
H3, h6: health effect - impact code added.Given the nature of the alleged incident, the product, could not be returned for evaluation.The clinical/medical investigation concluded that based on the limited information provided, a definitive clinical root cause cannot be concluded; however, an undiagnosed or pre-existing allergy/sensitivity to one or more of the material components in the dressing/adhesive and/or cleansing agent(s), the infusion itself, and/or concomitant medications/therapies cannot be ruled out as a potential contributing factors to the event, as the patient was diagnosed with dermatitis and a treatment plan initiated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.In addition, a review of complaint history based on the historical data revealed similar events for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.The review of the instructions for use documents for opsite flexigrid revealed in the precautions: if any signs of irritation, maceration, hypergranulation or sensitivity appear, discontinue use.During the body¿s normal healing process, unnecessary material is removed from the wound which will make the wound appear larger after the first few dressing changes.If the wound continues to get larger after the first few dressing changes, discontinue use and consult a healthcare professional.A review of the risk management file revealed this adverse event was previously identified.The anticipated risk level is still adequate.Finally, 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 an adverse skin reaction to the dressing materials, such as the adhesive.It can also be the result of backflow and leakage (if there is any) that could create high humidity in the periwound area.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: OPSITE FLEXIGRID 6X7CM CTN 100
• Common Device Name: 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: 20435531
• Report Number: 8043484-2024-00097
• Device Sequence Number: 7859976
• Product Code: KGX
• UDI-Device Identifier: 05000223046286
• UDI-Public: 5000223046286
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 4628
• Device Lot Number: 2221
• 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: 09/29/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/12/2024
• Supplement Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown