MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SKIN PREP CETRIMIDE WIPES X100; BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number 36005196

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported that severe rash/chemical burn occurred.Patient had a poweline catheter implant in her chest that require dressings.She have adhesive allergies that were previously managed by using skin prep.The supply company sent a smith and nephew brand adhesive remover and smith and nephew bran skin prep.However the skin prep is orange and green packaging while the adhesive remover is orange and dark orange.This resulted in us mixing up the two and using prevent remover without using skin prep, resulting in a severe allergic reaction that blistered and was essentially a chemical burn.

Manufacturer Narrative

H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that a patient experienced a severe rash/chemical burn.The patient had a poweline catheter implant in her chest that required dressings.She had adhesive allergies that were previously managed by using skin prep.The supply company sent a smith and nephew brand adhesive remover and smith and nephew bran skin prep.However, the skin prep is orange and green packaging while the adhesive remover is orange and dark orange.This resulted in them (the users) mixing up the two boxes and using prevent remover without using skin prep, resulting in a severe allergic reaction that blistered and was essentially a chemical burn.However, since skin prep cetrimide wipes were not even used, they could not caused the allergic reaction; and therefore, the issue does not meet the criteria to be a complaint nor to be reportable.

• Brand Name: SKIN PREP CETRIMIDE WIPES X100
• 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: 10570759
• MDR Text Key: 208085597
• Report Number: 8043484-2020-02932
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 36005196
• Device Lot Number: 75520
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention