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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM PROG VALVE INLINE W SG CHPV WITH SG

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RAYNHAM PROG VALVE INLINE W SG CHPV WITH SG Back to Search Results
Catalog Number 823832
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
It was reported that on (b)(6) 2019 a (b)(6) was implanted. On (b)(6) 2019, the patient appeared with subcutaneous hydrops, and during a ct check, it was found that the position of the valve was abnormal. On (b)(6) 2019, the patient had a revision surgery to retrieve the product and it was found that the spacer of the valve was dislodged. The valve was replaced with a same like product. No surgical delay reported.
 
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Brand NamePROG VALVE INLINE W SG
Type of DeviceCHPV WITH SG
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key9348927
MDR Text Key189882801
Report Number1226348-2019-00536
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K053107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823832
Device Lot Number203970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2018
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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