MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN SECURA EXTRA PROTECTIVE CREAMS; BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Device Handling Problem (3265)

Patient Problem Vomiting (2144)

Event Date 02/18/2022

Event Type  Injury  

Event Description

It was reported that the reporter's daughter ingested an unknown secura extra protective creams and was vomiting.The nurse advised to call poison control immediately.Further information is not available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, and with no other supporting information provided, the complaint could not be confirmed.A review of manufacturing records could not be performed for this event as no batch/lot number has been provided.The sequence of events as described does not constitute a manufacturing issue.No issues with the performance of the device were reported, the complaint is based on an off-label use of the product.A review of historical complaints found no other complaints relating to ingestion of the protective cream.No relevant historical escalations or corrective actions have been observed during a review of previous escalations.A medical review was conducted, confirming that the reported event constitutes an off-label use of the device, and does not represent a product malfunction.Aspects of procedural variance cannot be ruled out as a potential cause of the reported issue.The device instructions for use offers clear guidelines on the use of the product.It is clearly stated that the product is for external use only, and that it should always be kept out of the reach of children.Relevant risk files have been reviewed and found to adequately mitigate the risk caused by the complaint event.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.

• Brand Name: UNKN SECURA EXTRA PROTECTIVE CREAMS
• Type of Device: BANDAGE, LIQUID, SKIN PROTECTANT
• 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: 13720966
• MDR Text Key: 287276525
• Report Number: 8043484-2022-00099
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female