• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG Back to Search Results
Catalog Number NS9008
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/07/2021
Event Type  Injury  
Manufacturer Narrative
Unique device identification (udi): (b)(4). 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 valve was implanted in a patient due to inph (idiopathic normal pressure hydrocephalus) via l-p shunt on (b)(6) 2021, with 150mmh2o. The valve was used with the silascon lumbar catheter (manufactured by (b)(4), product code: 702-jj). On (b)(6) 2021, subcutaneous retention of the abdomen was observed after the set pressure was changed to 170mmh2o. Considering the rupture of the abdominal catheter, an operation was performed on (b)(6) 2021, to replace the abdominal catheter. The retention liquid was cerebrospinal fluid because of its color. The patient is in the follow up.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPECIAL DEVICE UNITIZED PROGRA
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
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12545730
MDR Text Key273737842
Report Number3013886523-2021-00414
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 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNS9008
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 Received09/13/2021
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

-
-