MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE XL 21X21 CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number 66801070

Device Problem Break (1069)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the allevyn life dressing was ripped, causing allergic reaction to patient.The allergic reaction was resolved with competitor's products(creams and dressings).All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history review found further instances of the reported event in the past years.The device was used for treatment.No samples were returned for analysis.Images provided confirmed a relationship between the event and the device.However, a definitive root cause could not be determined.The reported issue may be related to application or maintenance techniques.A clinical investigation concluded: two photos of the patient¿s sacrum show an adverse skin reaction.However, the information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).It was further communicated, the allergic reaction resolved with competitor's products (creams and dressings).Since it was reported the issue resolved after the removal of the s&n product and no further harm has been alleged to this patient; no further clinical/medical assessment is warranted at this time.The associated risk file contains the reported event.The instructions for use provides comprehensive instructions of the operation, use and limitations of the device.No further actions by smith + nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN LIFE XL 21X21 CTN10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10942422
• MDR Text Key: 219478058
• Report Number: 8043484-2020-04056
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223478070
• UDI-Public: 05000223478070
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66801070
• Device Catalogue Number: 66801070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other