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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORP. ALLODERM SELECT

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LIFECELL CORP. ALLODERM SELECT Back to Search Results
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).
 
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Brand NameALLODERM SELECT
Type of DeviceALLODERM SELECT
Manufacturer (Section D)
LIFECELL CORP.
MDR Report Key8939580
MDR Text Key155966644
Report NumberMW5089373
Device Sequence Number4
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/27/2019 Patient Sequence Number: 1
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