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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM STANDARD CATHETERS

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INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM STANDARD CATHETERS Back to Search Results
Catalog Number 823045
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 06/18/2021
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: 3013886523-2021-00296. A physician reported that certas valve was implanted to a (b)(6) year-old male patient via l-p shunt with a setting of 4 on (b)(6) 2021. Obstruction was suspected and the entire shunt system was removed and replaced on (b)(6) 2021. It was used with 823045 (hakim periton cath,120cm) and the silascon lumbar catheter (manufactured by (b)(4), product code: 702-jj). A surgical delay greater than 30 minutes was reported. The patient has recovered.
 
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Brand NameHAKIM PERITON CATH,120CM
Type of DeviceSTANDARD CATHETERS
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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ch-2400
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SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12140429
MDR Text Key260688921
Report Number3013886523-2021-00297
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K944222
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Yes
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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