MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE; RESPIRATOR, DECONTAMINATED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Discomfort (2330); Cough (4457)

Event Type  Injury  

Manufacturer Narrative

Ccds staff has been in contact with hcp, explaining the decontamination process, the chemicals used (sdss), and provided a link to faqs for hcps as well as suggesting airing out the masks prior to use.Evaluation of the device concluded that many compounds were detected and tentatively identified as compounds that are biogenic in origin (e.G.Plant or animal oils) or associated with fragrance and skincare products.None of the identities were conclusively established against an authentic reference standard.The biological analyses did not present microbiological evidence that is indicative of a causative agent for the adverse event.It is unknown if any of the detected compounds reported here are responsible for the adverse event report.The lack of a field sample negative control complicates interpretation of gc×gc results.It is unknown if any of the tentatively identified compounds were native to the mask as it was received at the facility or if those compounds were introduced elsewhere in the sample collection chain (e.G.Transportation, sample packaging, etc).Although no malfunction or serious injury of the decontaminated respirator has been confirmed, this report is required under the terms of the eua.

Event Description

User reported throat irritated, shortness of breath, coughing, choking feeling.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.

• Brand Name: NA
• Type of Device: RESPIRATOR, DECONTAMINATED
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE; 505 king ave; columbus OH 43201
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 10801528
• MDR Text Key: 215060186
• Report Number: 1523658-2020-00206
• Device Sequence Number: 1
• Product Code: QKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other