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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1825-1240S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report. Device remains implanted.
 
Event Description
The customer (b)(6) reported to (b)(6) that: "right leg swollen, hard to the touch. Remains swollen for several hours after observation, until lying down, even though the leg was left in the open air without restraint (no socks or tight clothes). Shortness of breath and feeling of tiredness, headaches (occipital lobe area and frontal lobe area), very slight prickling sensation in the heart. The swollen legs, i observed them from (b)(6) 2006 to (b)(6) 2021, that's what made me decide to fill in these fields. ".
 
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Brand NameFEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12583904
MDR Text Key274974071
Report Number0009610622-2021-00732
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K010801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1825-1240S
Device Catalogue Number18251240S
Device Lot NumberK038533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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