MAUDE MDR 9622103

MDR report key
9622103
Report number
MW5092434
Event key
0
Event type
3
Date of event
2019-04-18
Date received
2020-01-22
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
1BIOZORBMARKER, RADIOGRAPHIC, IMPLANTABLEFOCAL THERAPEUTICSNEUI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2201. S

Event Narratives#

D

Patient 1

I HAD A LUMPECTOMY FOR BREAST CANCER ON (B)(6) 2019. THE SURGEON IMPLANTED A ?BIOZORB?. THE LOCATION OF THE BIOZORB IS AT THE BOTTOM OF MY ARMPIT AND IS PAINFUL BECAUSE IT GETS PUSHED AGAINST MY RIBS BY MY ARM. WHILE THE BIOZORB IS DEFINITELY GETTING SMALLER, IF I HAD KNOWN THAT IT WOULD BE PAINFUL AND IRRITATING FOR THIS LONG, I NEVER WOULD?VE ALLOWED THE SURGEON TO PUT IT IN ME. ALSO, THE EXCUSE FOR INSERTING THE BIOZORB WAS SO THE FOLLOWING RADIATION TREATMENT COULD TARGET THE TUMOR AREA. HOWEVER, BECAUSE I AM SMALL CHESTED, THE RADIATION ONCOLOGIST WAS UNABLE TO UTILIZE THIS FEATURE DUE TO THE POTENTIAL SCARRING A RADIATION BOOST WOULD CAUSE. SO THERE WAS ACTUALLY NO REASON FOR THIS DEVICE TO BE USED ON ME. I ALSO HAVE BEEN SUFFERING WITH AXILLARY WEB SYNDROME, WHICH HAS BEEN BEING TREATED SINCE (B)(6) OF 2019. BUT THE ?CORDING? CONTINUES TO BE TROUBLESOME AND SEEMS TO RUN RIGHT THROUGH THE TUMOR BED. THE PHYSICAL THERAPIST SUSPECTS THAT THE BIOZORB IS CAUSING THE CORDING TO CONTINUE TO BE AN ISSUE. FDA SAFETY REPORT ID # (B)(4).