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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PREC RT ANG RES UNTZ MH PRECISION

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INTEGRA LIFESCIENCES MANSFIELD PREC RT ANG RES UNTZ MH PRECISION Back to Search Results
Model Number 82-3284
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
Complaint sample was not returned for evaluation (remains implanted); therefore, an evaluation of the device could not be performed. Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies. 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 facility reported the patient had an unknown allergy after a hakim valve placement.
 
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Brand NamePREC RT ANG RES UNTZ MH
Type of DevicePRECISION
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key11510109
MDR Text Key240588716
Report Number3013886523-2021-00120
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
Reporter Occupation
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2019
Device Model Number82-3284
Device Catalogue Number823284
Device Lot NumberCRHBFH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/13/2014
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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