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

Model Number	66801070
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a sarcoma resection surgery an allevyn life xl 21x21 ctn10 was used on the patient, the silicone plates was placed in the bony prominences accordantly to the institutional protocol patient was in ventral position was required during procedure, surgery lasted for 1 hour and 30 minutes and when returning patient to ddh position and after removing the plates it was noticed that the patient's skin had macerations and looked like a kind of "glue".This problem was treated using 5 sachets of sting free adhesive remover.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Maceration typically resolves on its own once the skin is dry or with minor medical intervention (e.G., dressing change).Maceration that does not result in significant wound deterioration and that does not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure is considered not reportable pursuant to 21 cfr §803.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12800065
• Report Number: 8043484-2021-01952
• Device Sequence Number: 12159841
• Product Code: NAD
• UDI-Device Identifier: 05000223478070
• UDI-Public: 05000223478070
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 66801070
• Device Catalogue Number: 66801070
• Device Lot Number: 202110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown