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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM CHPV

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INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM CHPV Back to Search Results
Catalog Number 823101
Device Problem Infusion or Flow Problem (2964)
Patient Problem Failure of Implant (1924)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
The hakim valve was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this and similar issues. At present, we consider this complaint to be closed.
 
Event Description
A physician reported the hakim valve was implanted to a patient via ventricular peritoneal shunt on (b)(6) 2020 with unknown setting. There was suspicion of obstruction due to poor flow. Therefore, the valve was removed and replaced on (b)(6) 2021.
 
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Brand NameMEDOS PROG INFANT VALVESYSTEM
Type of DeviceCHPV
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
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12544686
MDR Text Key273754855
Report Number3013886523-2021-00405
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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