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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GRIFOL TALECRIS PLASMA RESOURCES / LABORATORIOS GRIFOLS, S.A. IV; SET, I.V. FLUID TRANSFER
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GRIFOL TALECRIS PLASMA RESOURCES / LABORATORIOS GRIFOLS, S.A. IV; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 01/07/2022
Event Type  Injury  
Event Description
When to plasma center where they didn't know what they were doing, they put me on a broken machine purposely.They busted my main vein, i lost blood a lot.I have been getting pain in my hands; i have been getting sick a lot now.Also there a worker who has this problem where she likes to touch the donors.I tried to get them in trouble but nothing happens to them.I have pics of my harms, just don't know how to upload them but they really don't need to be opened; they do this to a lot of people.Fda safety report id # (b)(4).
 
Event Description
When to plasma center where they didn't know what they were doing, they put me on a broken machine purposely.They busted my main vein, i lost blood a lot.I have been getting pain in my hands; i have been getting sick a lot now.Also there a worker who has this problem where she likes to touch the donors.I tried to get them in trouble but nothing happens to them.I have pics of my harms, just don't know how to upload them but they really don't need to be opened; they do this to a lot of people.Fda safety report id # (b)(4).
 
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Brand Name
IV
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
GRIFOL TALECRIS PLASMA RESOURCES / LABORATORIOS GRIFOLS, S.A.
MDR Report Key13591923
MDR Text Key286141546
Report NumberMW5107660
Device Sequence Number2
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/18/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/23/2022
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
Patient SexMale
Patient Weight127 KG
Patient RaceWhite
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