MAUDE Adverse Event Report: CHEST EXPANDER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Extreme Exhaustion (1843); Unspecified Infection (1930); Positive antinuclear antibodies (ANA) (2015)

Event Type  Injury  

Event Description

Saline filled chest expanders placed post mastectomy caused elevated ana antibodies, severe joint pain specifically in hands and wrists causing doctors to suspect autoimmune disease, severe brain fog, extreme exhaustion and numerous infection.Symptoms have decreased dramatically and ana antibodies normal since having them removed.

• Brand Name: CHEST EXPANDER
• Type of Device: CHEST EXPANDER
• MDR Report Key: 5865530
• MDR Text Key: 51921064
• Report Number: MW5063982
• Device Sequence Number: 1
• Product Code: LCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/07/2016

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 57