MAUDE Adverse Event Report: SHILEY 3.0PEF

Model Number 3.0 PEF

Device Problem Positioning Problem (3009)

Patient Problems Granuloma (1876); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Respiratory Distress (2045); Discomfort (2330)

Event Date 06/26/2015

Event Type  Injury  

Event Description

As soon as i was required to change her trach from a shiley 3.0 ped to the 3.0 pef cuffless, she formed a new granuloma that is constantly causing infection in her stoma, bleeding and she also has trouble breathing occasionally.The trach sits differently and she complains that it is hurting her.I am getting it changed soon, but it has caused her great pain and discomfort.I am actually pretty upset that we were even forced to go with the change because she never had a problem with the 3.0ped.

• Brand Name: SHILEY 3.0PEF
• Type of Device: SHILEY 3.0PEF
• MDR Report Key: 4888443
• MDR Text Key: 6018154
• Report Number: MW5043486
• Device Sequence Number: 1
• Product Code: BTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2015
• Device Model Number: 3.0 PEF
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2015
• Patient Sequence Number: 1
• Treatment: BACTRIM; TOBI; ALBUTEROL
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Weight: 14