MAUDE MDR 8196901

MDR report key: 8196901
Report number: 1018233-2018-06158
Event key: 0
Event type: 3
Date received: 2018-12-26
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 3
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: YONIC ANDERSON
Address: 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone: 770-770-7707
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE	INTRA-ABDOMINAL PRESSURE MONITORING DEVICE	C.R. BARD, INC. (COVINGTON) -1018233	PHU	IAP001	IAP001	NGCS1305				Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2018-12-26	0

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT THE DEVICE HAD A HOLE IN IT. THIS WAS NOTED PRIOR TO USE.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00860003478707	TraumaGuard Intra-abdominal Pressure-Sensing System	SENTINEL MEDICAL TECHNOLOGIES	PHU	2024-07-06
00860003478721	TraumaGuard Intra-abdominal Pressure-Sensing System	SENTINEL MEDICAL TECHNOLOGIES	PHU	2024-07-06
00860003478745	TraumaGuard Intra-abdominal Pressure-Sensing System	SENTINEL MEDICAL TECHNOLOGIES	PHU	2024-07-06
00860003478752	TraumaGuard Intra-abdominal Pressure-Sensing System	SENTINEL MEDICAL TECHNOLOGIES	PHU	2024-07-06
00860011933106	TraumaGuard Intra-abdominal Pressure-Sensing System	SENTINEL MEDICAL TECHNOLOGIES	PHU	2024-07-06
00850019755107	Accuryn SmartFoley IAP UO Temp Tray System 12Fr	POTRERO MEDICAL, INC.	PHU	2023-03-30
00850019755114	Accuryn SmartFoley IAP UO Temp Tray System 14Fr	POTRERO MEDICAL, INC.	PHU	2023-03-30
00850019755008	Accuryn Temperature Cable	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755206	Accuryn Temperature Cable Adapter	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755213	Accuryn Monitor Short Floor Stand	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755220	Accuryn Monitor Floor Stand	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755237	Accuryn Monitor Mount with Clamp	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755244	Accuryn Monitor High Mount	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755251	Accuryn Monitor High Mount & Floor Stand	POTRERO MEDICAL, INC.	PHU	2022-10-19
00850019755121	Accuryn SmartFoley IAP UO Temp Tray System 16Fr	POTRERO MEDICAL, INC.	PHU	2021-09-29
00868475000235	Accuryn Monitor	POTRERO MEDICAL, INC.	PHU	2018-01-22
00801741121098	Bard® Intra-abdominal Pressure Monitoring Device	C. R. Bard, Inc.	PHU	2016-09-07
10801741121095	Bard® Intra-abdominal Pressure Monitoring Device	C. R. Bard, Inc.	PHU	2016-09-07

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K210570	PHU	TraumaGuard Intra-abdominal Pressure Sensing System	Sentinel Medical Technologies, LLC	2021-10-29
510(k)	K070201	PHU	BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001	C.R. Bard, Inc.	2007-08-01