MAUDE Adverse Event Report: MOLDEX MOLDEX; SURGICAL 95 RESPIRATOR

Model Number	1512
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Cough (4457)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Background: medwatch report #mw5097092 received on 10/21/20.Phone call attempt to initial reporter, (b)(6) was made on 10/29/2020 at 2 pm pst, but was sent to voice mail.Email requesting a call back from initial reporter was sent to (b)(6) by (b)(6) on (b)(6) 2020 at 2:32 pm pst.(b)(6) emailed back on 10/30/2020 and agreed to a call that day at 1pm est.Key points from call with (b)(6) at 1 pm est.On (b)(6) 2020 with (b)(6).Med watch reports #mw5097092, #mw5097094, #mw5096408 were discussed in this call as all were issued by the same initiator (ms lindsay campbell) and were citing the same moldex surgical 95 respirator model number, along with similar user symptoms and outcome.She indicated she had no concerns with the moldex masks but that the reprocessing from battelle was causing herself and many others to have symptoms as noted in the medwatch reports listed above.She advised that the masks causing the reported symptoms were the moldex 1512 model that had been reprocessed by battelle.She advised that in all cases when the reprocessed mask was replaced by a brand-new mask, there were no further symptoms.She advised that they had similar problems with reprocessed masks from other mfrs.And were no longer using reprocessed masks.She advised that the masks that caused these symptoms were all immediately disposed of and therefore not available for moldex to examine.Conclusion: the incident described by the initiator of this subject medwatch report was also reported in an earlier medwatch report #mw5096408.This incident along with the aforementioned incident are believed to be the result of processing problems from the decontamination process that was performed by battelle.This is supported by the initiator's statement that when the reprocessed mask was replaced with a new, non-reprocessed mask the symptoms disappeared.Moldex surgical n95 respirators are single use devices and are not recommended by moldex for reprocessing, decontamination or reuse.Further, moldex has not received any prior complaints or reports of these symptoms from use of it's product.Moldex acknowledges that the fda has issued emergency use authorization for the decontamination/reprocessing of disposable respirators, but has not designed for, nor recommends the reuse of o.R.Decontamination of it's products.
Event or Problem Description
Coughing, sneezing, runny nose, red rash like reaction around face.

• Brand Name: MOLDEX
• Common Device Name: SURGICAL 95 RESPIRATOR
• Manufacturer (Section D): MOLDEX; 10111 jefferson blvd; culver city CA 90232
• MDR Report Key: 11037942
• Report Number: 1000098753-2020-00002
• Device Sequence Number: 16460084
• Product Code: MSH
• UDI-Device Identifier: 00092311151205
• UDI-Public: 00092311151205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 1512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other