FDA.reportPublic FDA data

MAUDE MDR 9835022

MDR report key
9835022
Report number
9617229-2020-04475
Event key
0
Event type
3
Date received
2020-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. MICHELLE BURGESS
Address
12331-A RIATA TRACE PARKWAY BUILDING 3 AUSTIN TX 78727 US
Phone
737-737-7372
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STYLE 133FV TISSUE EXPANDEREXPANDER, SKIN, INFLATABLEALLERGAN (COSTA RICA)LCJUNK STYLE 133FVNIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1601. R

Event Narratives#

N

Patient 1

FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF INFECTION (UNKNOWN ONSET) IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION WAS INFECTION (UNKNOWN ONSET).

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED "INFECTION REQUIRING REMOVAL" ON AN UNSPECIFIED SIDE. THIS RECORD IS FOR THE LEFT SIDE. EXPLANT STATUS IS UNKNOWN.