MAUDE Adverse Event Report: TIDI PRODUCTS LLC C-ARMOR; DRAPE

Model Number	5523
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Similar product of the same part number were inspected to support the investigation.As part of the investigation, an inspection of existing inventory was performed with no defects observed.This is the first complaint associated with this lot number.Corrective action is being implemented at the manufacturing facility.All complaints are trended and reviewed on a monthly basis.As part of this monthly review this failure mode will be assessed.(b)(4).During a retrospective review with the fda help desk, it was determined that this complaint was initially sent to the test region and not the fda production region.Therefore, this required a resubmission of this mdr.
Event or Problem Description
During surgery, surgeon and staff noted black fragments from the hook/loop portion of the drape had fallen into the wound during the course of surgery.The visible fragments were removed and the wound was irrigated.Adverse reaction is unknown.Patient (b)(6), pt# (b)(6), orif, left patella.During a retrospective review with the fda help desk, it was determined that this complaint was initially sent to the test region and not the fda production region.Therefore, this required a resubmission of this mdr.

• Brand Name: C-ARMOR
• Common Device Name: DRAPE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah 54956
• MDR Report Key: 9242464
• Report Number: 2182318-2019-00001
• Device Sequence Number: 16195155
• Product Code: KKX
• UDI-Device Identifier: 00618125140152
• UDI-Public: 00618125140152
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 5523
• Device Catalogue Number: 50 C-ARMOR
• Device Lot Number: 020785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR