MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SKIN-PREP WIPES BULK 1 CASE 01; BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number 420471

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

It was reported that the skin-prep product have seal integrity issues.It is unknown if a backup was available and if a patient was involved.

Manufacturer Narrative

H3, h6: the device intended to be used in treatment was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause, probable root causes may include operator error during manufacturing process.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, a complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: SKIN-PREP WIPES BULK 1 CASE 01
• 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
• MDR Report Key: 11617700
• MDR Text Key: 243894936
• Report Number: 8043484-2021-00765
• Device Sequence Number: 1
• Product Code: NEC
• UDI-Device Identifier: 30040565116519
• UDI-Public: 30040565116519
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Catalogue Number: 420471
• Device Lot Number: 08890
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1