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

Model Number	66801070
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during treatment, the dressing did not absorb wound exudate, as expected.When changing the dressing, the wound fluid was gathering under the dressing.This led to soaking of the wound edge.Patient outcome is unknown.It is unknown how was the wound treated.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, has not been returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.It was reported that the dressing did not absorb wound exudate as expected.Factors that can contribute to the reported event include that the dressing was saturated and needed to be changed.Our clinical investigation 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 based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN LIFE XL 21X21 CTN10
• Common Device Name: 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: 10963570
• Report Number: 8043484-2020-04087
• Device Sequence Number: 13670871
• Product Code: NAD
• UDI-Device Identifier: 05000223478070
• UDI-Public: 05000223478070
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 66801070
• Device Catalogue Number: 66801070
• Device Lot Number: 201905
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other