MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE 5CM X 5CM; DRESSING, WOUND, OCCLUSIVE

Catalog Number 66800247

Device Problems Nonstandard Device (1420); Material Integrity Problem (2978)

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Complaint: (b)(4).

Event Description

It was reported that an allevyn gentle was used on the wound, once, for 12 hours.After that, the leg became swollen, there was severe itching and peeled redness.When removing the bandage, silicone remained in the wound and had to be removed.Its is unknown how the condition was treated.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.Medical review concluded.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Possible causes include, storage of the device and or a raw material issue.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch lot number was provided, rendering a review of the device history not possible, complaint history review found further related cases.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.The complaint history review found further similar incidents in the past years.Medical review concluded: no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Possible causes include, allergic reaction to silicone, dressing left on too long, the ifu offers further guidance.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: ALLEVYN GENTLE 5CM X 5CM
• 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: 11038357
• MDR Text Key: 222364479
• Report Number: 8043484-2020-04325
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800247
• Device Lot Number: 1926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention