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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SOLA 500/700 LIGHTS

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DRÄGERWERK AG & CO. KGAA SOLA 500/700 LIGHTS Back to Search Results
Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem Abrasion (1689)
Event Date 02/02/2022
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that after an only weakly perceptible noise, the support arm broke off and injured the user on the arm (slight abrasion). The complete lamp with support arm landed on the floor.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that after an only weakly perceptible noise, the support arm broke off and injured the user on the arm (slight abrasion). The complete lamp with support arm landed on the floor.
 
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Brand NameSOLA 500/700
Type of DeviceLIGHTS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key13557406
MDR Text Key285808555
Report Number9611500-2022-00053
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
PMA/PMN Number
K010724
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/18/2022 Patient Sequence Number: 1
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