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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER

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INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER Back to Search Results
Catalog Number 823074
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
2 of 2 reports. Other mfg report number: 3013886523-2021-00402. A physician reported a certas plus valve (id 828814 ) and a bactiseal peritoneal catheter (id 823074) were implanted to a patient via ventricular peritoneal shunt on an unknown date with an unknown setting. The set pressure could not be changed and valve obstruction was suspected. The patient had a head injury that caused a fracture in the skull near the valve and there was also suspicion that the valve was damaged. The valve and catheter were removed and replaced on (b)(6) 2021.
 
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Brand NameBACTISEAL PERITONEAL CATHETER
Type of DeviceBACTISEAL PERITONEAL CATHETER
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 Key12523920
MDR Text Key273096077
Report Number3013886523-2021-00403
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K102589
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 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823074
Was Device Available for Evaluation? No Answer Provided
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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