FDA.reportPublic FDA data

MAUDE MDR 9871707

MDR report key
9871707
Report number
MW5093901
Event key
0
Event type
3
Date of event
2019-11-04
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NATRELLE SMOOTH MODERATE HIGH TISSUE EXPANDER 400CCEXPANDER, SKIN, INFLATABLEALLERGANLCJ133 SMX-12-TI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

D

Patient 1

REPORTER STATED THAT SHE RECEIVED A TISSUE EXPANDER AFTER A MASTECTOMY ON (B)(6) 2019. SHE ALLEGED THAT SHE WAS NOT PROVIDED ANY ASSISTANCE AFTER DISCHARGE AND WAS SENT HOME WITH A HEMATOMA. WITHIN A FEW DAYS SHE HAD BLUE AND PURPLE SWELLING ON HER ENTIRE CHEST AREA. SHE WENT BACK FOR A F/U AND WAS SEEN BU AND PA AND NOT THE DR. SHE WAS TOLD THAT SHE WOULD NEED TO "CLEAN UP THE EDGES AND DRAIN BLOOD FROM THE SITE". SHE STATED THAT THEY COMPLETELY OPENED HER UP AND REMOVED 2.5IN OF SKIN. SHE REPORTED THAT IT WAS AS IF SHE HAD 2 SURGERIES IN 4 DAYS. THREE MONTHS LATER, SHE WENT TO A DIFFERENT DR AND WAS TOLD THAT SHE HAD A SEROMA AND IT NEEDED TO BE DRAINED. SHE STATED THAT HER INCISION WOULD NOT HEAL, SHE HAS HAD "A LOT OF COMPLICATIONS" AND HAS WASTED A LOT OF MONEY. SHE INSISTED THAT THESE TISSUE EXPANDERS ARE NOT MADE CORRECTLY TO FIT THE HUMAN BODY AND THAT THE FDA "SHOULD DO SOMETHING ABOUT IT."