MAUDE MDR 7176012

MDR report key: 7176012
Report number: 1018233-2018-00075
Event key: 0
Event type: 3
Date of event: 2017-12-15
Date received: 2018-01-09
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 2
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: AMY GRAVLEY
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	NGAV3640				Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2018-01-09	0

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT WATER LEAKAGE OCCURRED BETWEEN THE SAMPLE PORT AND THE VALVE PORT AS PRIMING WAS BEING PERFORMED.

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

MAUDE MDR 7176012

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

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