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

Model Number	5536
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Affected product was not returned to the manufacturer.However, photographs were provided and manufacturer was able to confirm the contamination of the product in its packaging.At this time, the investigation is ongoing, and no further information is available.Manufacturer reference file: (b)(4).
Event or Problem Description
Customer reported a foreign material, possibly a bug, was found inside the sealed and sterile package of a drape cover.No further information was provided.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: C-ARMOR
• Common Device Name: C-ARMOR DRAPE KIT
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 7795162
• Report Number: 2182318-2018-00005
• Device Sequence Number: 19111720
• Product Code: PUI
• UDI-Device Identifier: 01618125140168
• UDI-Public: 01618125140168
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 07/19/2018

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: 08/04/2022
• Device Model Number: 5536
• Device Catalogue Number: 5536
• Device Lot Number: 018301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1