FDA.reportPublic FDA data

MAUDE MDR 9662316

MDR report key
9662316
Report number
3005099803-2020-00283
Event key
0
Event type
3
Date of event
2020-01-20
Date received
2020-02-03
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
CAROLE MORLEY
Address
300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPACEOAR SYSTEMABSORBABLE PERIRECTAL SPACERAUGMENIX, INC.OVBSO-4101SO-41010005201901R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0301. H; 2. R

Event Narratives#

N

Patient 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. A METAL MARKER WAS ALSO PLACED PRIOR TO IMPLANTING SPACEOAR. REPORTEDLY, LIDOCAINE WAS USED FOR LOCAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE AND CONSCIOUSNESS LEVEL DECREASED. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) FOR TREATMENT. THE PATIENT EXPERIENCED AN ALLERGIC REACTION, AND A RASH WAS NOTED BY THE TREATING PHYSICIAN. THE PATIENT RECEIVED AN INTRAMUSCULAR EPINEPHRINE INJECTION AND REMAINED UNDER OBSERVATION. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF THE PATIENT'S ALLERGIC REACTION COULD NOT BE CONFIRMED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020.