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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RMS MEDICAL PRODUCTS HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS SUBCUTANEOUS NEEDLE SET

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RMS MEDICAL PRODUCTS HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS SUBCUTANEOUS NEEDLE SET Back to Search Results
Model Number RMS12609
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Reaction, Injection Site (2442)
Event Type  Injury  
Event Description
Patient was infusing dilaudid subcutaneous infusion for a few months. Initially, the patient was experiencing some redness during the infusion. Now the redness has turned to blisters. The clinical coordinator does not believe this incident is related to faulty product but to an allergic reaction. The patients blisters did become infected and required treatment with antibiotics.
 
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Brand NameHIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS
Type of DeviceSUBCUTANEOUS NEEDLE SET
Manufacturer (Section D)
RMS MEDICAL PRODUCTS
24 carpenter road
chester NY 10918
Manufacturer (Section G)
RMS MEDICAL PRODUCTS
24 carpenter road
chester NY 10918
Manufacturer Contact
fred ma
24 carpenter road
chester, NY 10918
8454692042
MDR Report Key7886863
MDR Text Key120691140
Report Number1318360-2018-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2019
Device Model NumberRMS12609
Device Lot Number7.191/16
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 Received09/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/18/2018 Patient Sequence Number: 1
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