MAUDE Adverse Event Report: JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD. MEDICAL ACTION INDUSTRIES INC.; OR TOWEL

Model Number	ORT400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint opened under complaint number (b)(4).A trending analysis was performed; there are no trends related to this defect as pertains to the product.Site will continue to track and trend for this issue.The supplier has been notified of the issue.
Event or Problem Description
Received customer complaint from distributor regarding event whereby or towel produced lint into surgical site during an unidentified procedure.Per distributor, after multiple good-faith attempts, the end-user remains unable or unwilling to provide additional information regarding the alleged event in order to contribute to further complaint investigation.There are no other details obtained as corresponds to the report.The complaint item is reference number (b)(4), or towel (non-xray detectable), medical action industries branded.The complaint lot was not reported or obtained from end-user.

• Brand Name: MEDICAL ACTION INDUSTRIES INC.
• Common Device Name: OR TOWEL
• Manufacturer (Section D): JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.; 18 baochang road north; haian jiangsu, china 226631
• MDR Report Key: 8493560
• Report Number: 1030451-2019-00001
• Device Sequence Number: 1018903
• Product Code: PUI
• UDI-Device Identifier: 50809160000715
• UDI-Public: 50809160000715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: ORT400
• Device Catalogue Number: ORT400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/08/2019
• 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: Required Intervention