MAUDE Adverse Event Report: RESPIRATORY TECHNOLOGIES INC. INCOURAGE DEVICE; PERCUSSOR, POWERED-ELECTRIC

Model Number	R500055-000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage device caused a hernia.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an incourage device allegedly caused a hernia.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: INCOURAGE DEVICE
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES INC.; 5905 nathan lane north; plymouth MN 55442
• MDR Report Key: 11671692
• Report Number: 3004961434-2021-00004
• Device Sequence Number: 3149723
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K051383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: Lay User/Patient
• Device Model Number: R500055-000
• Device Catalogue Number: R500055-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other