MAUDE Adverse Event Report: AVID MEDICAL GENERAL SURGERY TRAY (KIT)

Model Number	VALV219-02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Avid medical complaint # (b)(4).Avid medical received a complaint on 12/12/2022 that stated "when the 3m 1015 drape was removed, the adhesive lifted the patient¿s skin." medical treatment was provided.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 10jan2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that o&m halyard, inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.During this inspection, no issues were detected.Photos and samples were not received, details have been forwarded to 3m with a request for documentation outlining their findings and any corrective actions taken.An inspection of our in-house stock was completed.We no longer have the complained lot on hand.As a precaution additional lots on hand were inspected.During the review the reported issue could not be detected.No supplier response has been obtained to-date from 3m.Avid medical will continue to track and trend for any future recurrence of this issue and evaluate for further corrective actions.All information reasonably known as of 25apr2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that o&m halyard, inc.Product is defective or caused serious injury.

• Brand Name: GENERAL SURGERY TRAY (KIT)
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AVID MEDICAL; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): AVID MEDICAL; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16132347
• Report Number: 1047429-2022-00001
• Device Sequence Number: 12643374
• Product Code: LRO
• UDI-Device Identifier: 10809160364796
• UDI-Public: 10809160364796
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: VALV219-02
• Device Catalogue Number: VALV219-02
• Device Lot Number: 1520686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown