MAUDE Adverse Event Report: ALLERGAN NATRELLE INSPIRA COHESIVE BREAST IMPLANTS

Model Number REF 133MV-13-T

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Nausea (1970); Sepsis (2067); Septic Shock (2068); Swelling (2091); Vomiting (2144); Chills (2191); Malaise (2359)

Event Date 07/20/2019

Event Type  Injury  

Event Description

Received tissue expanders and breast implants for the second time on (b)(6) 2019, began feeling sick in may, severe fatigue, nausea / vomiting, hot/cold spells, temperatures, loss of appetite, overall feeling very bad.Continued to see drs, receive lab work multiple times, all showing i had an infection going on, but did not know from where until (b)(6) 2019, when seen in the emergency room, after seeing my right breast two times the size of the left, extremely red and very hot to the touch, temps at 103-104.Was diagnosed with severe sepsis, septic shock, and was taken to surgery for immediate removal of my implants and expanders.Was admitted to hosp where i received fluids, iv antibiotics, sepsis protocols were in place.Received a pic line, so i could continue iv antibiotic treatment for two add'l weeks at home after my discharge from the hosp.I continue to struggle with being sick, nausea / vomiting, hot/cold spells, severe fatigue, loss of appetite, basically the inability to be active in any way currently to date.Fda safety report id# (b)(4).

• Brand Name: NATRELLE INSPIRA COHESIVE BREAST IMPLANTS
• Type of Device: NATRELLE INSPIRA COHESIVE BREAST IMPLANTS
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 8939580
• MDR Text Key: 155966644
• Report Number: MW5089373
• Device Sequence Number: 2
• Product Code: FTR
• Combination Product (y/n): N
• 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: 08/26/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF 133MV-13-T
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 59 YR
• Patient Weight: 64