MAUDE Adverse Event Report: C-ARMOR; C-ARMOR DRAPE

Model Number	5523
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Affected product was returned and manufacturer was able to confirm the reported foreign material in the product.Inspection of the material determine it is non-biological in origin.At this time, the investigation is ongoing and no further information is available.(b)(4).
Event or Problem Description
Customer detected foreign contaminant in sterile drape while prepping the patient.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
• MDR Report Key: 7807731
• Report Number: 2182318-2018-00006
• Device Sequence Number: 1468981
• Product Code: PUI
• UDI-Device Identifier: 01618125140151
• UDI-Public: 01618125140151
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: No Information
• Device Expiration Date: 12/22/2022
• Device Model Number: 5523
• Device Lot Number: 019269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1