• 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 HOLTER SALMON RICKHAM LP RESERVOIRS

  • 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 HOLTER SALMON RICKHAM LP RESERVOIRS Back to Search Results
Model Number 82-1617
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling/ Edema (4577)
Event Date 04/27/2021
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
Study: to treat patient's underlying disease (cln2-late infantile neuronal ceroid lipofuscinosis type 2), the patient received intraventricular enzyme therapy every 14 days via an implanted rickham reservoir (821617). The reservoir was implanted on (b)(6) 2020. On (b)(6) 2021, there were repeated swellings in the face and wet bandages after the enzyme therapy, therefore, the reservoir was replaced on (b)(6) 2021. Patient left the clinic on (b)(6) 2021 without any issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHOLTER SALMON RICKHAM LP
Type of DeviceRESERVOIRS
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 Key13860796
MDR Text Key289856673
Report Number3013886523-2022-00098
Device Sequence Number1
Product Code JXG
UDI-Device Identifier10886704040477
UDI-Public(01)10886704040477(17)241231(10)4403106
Combination Product (y/n)N
PMA/PMN Number
K102961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number82-1617
Device Catalogue Number821617
Device Lot Number4403106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-