COMPRESSION GARMENT / BRA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for COMPRESSION GARMENT / BRA manufactured by Unk.

Event Text Entries

[143423871] I underwent cosmetic surgery through a travel makeover abroad in (b)(6). Had a complete mommy makeover with 540 cc gummy bear implants, abdominoplasty, 8 areas liposuction and a fat transfer brazilian lift. I had extreme pains worsening in right arm and right breast on the day of my surgery which, they said was normal. The nurse didn't compress my abdominal drain, they didn't have my lactated ringers with analgesia dripping for 6 hours. And wouldn't assess my arm. Every time i complained they said it was normal. For 10 days, on my last assesment i was nauseated ever, chills, body aches, and weak. Warmth redness and swelling. Still they blamed anemia and were going to allow me to leave in the morning back to the usa. Being a nurse, i demanded labs. The labs showed a wbc count of 18. 5. Then they still said no infection because no drainage. They made me take a urinalysis. Said it could be a uti. With no urinary symptoms. Finally ua came back negative and they agreed to drain my right breast. I woke up from anesthesia explanted 10 days after being implanted. After surgery in recovery the nurse didn't put in a catheter and i began having severe bladder spasms. I begged for a catheter. They tried to get me laying flat to use a metal bed pan. I became frantic and kicked pan off table and pulled things from my arms screaming for my fiance because they weren't listening to me. They went, got him. Finally took three nurses to put in a catheter that immediately drained 600 cc. Upon discharge the nurse attempted to put the catheter without deflating balloon. I stopped her. Then the other nurse broke the needle off the blue hub of a 10 cc syringe with needle. I told her it wouldn't work. She tried anyways. Then figured out how to, after i showed her. I refused to stay 5 days and allow my fiance to leave me there because i feared for my health and safety. I got discharged and 6 am and got on a plane by 830 am fearing pulmonary embolism or blood clots for 14 hours to get home. They didn't ever give me written discharge instructions. They withdrew yellow pus from my right breast and sent it for culture. It showed abundant gram negative rods without growth. Prior to surgery i was started on levaquin. They cut down my areolas which was my number one concern during my first meeting that i did not want. They kept telling me i was sensitive. They order a too small compression garment and bra and fussed for me to wear it. When i finally did, the bra caused bruising which is still there today. Then the dr says that it is too small not to wear, i told them that the moment he gave it to me, i had to pay (b)(6) dollars for it. Then they make me pay the explant because they said it was not the dr's fault that it was rejection not infection. The implant was discolored after ten days. Only one was. Then on the warranty they claimed they gave me the day of my surgery which they didn't had the implant reference numbers switched showing on wrong side. The discolored implant still smells of infection. They claim a zero infection rate. They are frauds. The makeover travel agent even told us at dinner that her butt implants caused infection and she had to get them redone. Now she is saying it was rejection, not infection. I called her out because i found someone with a similar story and it looks like she is making false reviews to make company look good. Upon returning to us, i ended up in the hosp for infection wbc count 13. 5. It took 7 pounds of 3 different antibiotics to get wbc count to 8. 5 and i had to have 60 cc fluid drained from swollen right breast. Dilaudid for pain around the clock. I contacted sebbin about the implant discoloring after 10 days and they refused to give me any info. I have a warranty. The dr even switched the implant numbers on the warranty cards. Once implants smells and discolored after 10 days of being implanted. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086151
MDR Report Key8549866
Date Received2019-04-24
Date of Report2019-04-18
Date of Event2019-03-27
Date Added to Maude2019-04-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameCOMPRESSION GARMENT / BRA
Generic NameCOMPRESSION GARMENT / BRA
Product CodeMHW
Date Received2019-04-24
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 1

Brand NameSEBBIN 540 CC BREAST IMPLANTS
Generic NameBREAST, PROSTHESIS, INFLATABLE SALINE IMPLANT
Product CodeFWM
Date Received2019-04-24
Model NumberLSC73540
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGROUPE SEBBIN

Device Sequence Number: 2

Brand NameSEBBIN 540 CC BREAST IMPLANTS
Generic NameBREAST, PROSTHESIS, INFLATABLE SALINE IMPLANT
Product CodeFWM
Date Received2019-04-24
Model NumberLSC73540
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerGROUPE SEBBIN

Device Sequence Number: 3

Brand NameNEEDLE, HYPODERMIC
Generic NameNEEDLE, HYPODERMIC
Product CodeFMI
Date Received2019-04-24
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No3
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-04-24

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