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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG Back to Search Results
Catalog Number 823832
Device Problem Inaccurate Flow Rate (1249)
Patient Problem Injury (2348)
Event Date 04/30/2020
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
The physician reported that the hakim valve (823832 prog valve inline w sg) flow rate seemed to be different than usual. The valve was implanted with unknown initial setting and unknown date. The patient¿s symptoms were difficult to control with setting of 50mmh2o. A ct was performed, and it did not show any occlusion. Therefore, the valve was replaced with a new valve with the setting of 140 mmh2o. The patient is doing well.
 
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Brand NamePROG VALVE INLINE W SG
Type of DeviceCHPV WITH SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10280441
MDR Text Key202598179
Report Number1226348-2020-00244
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K053107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number823832
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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