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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAN ALLEN SURGICAL TRENGUARD; TABLE AND ATTACHMENTS, OPERATING-ROOM
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DAN ALLEN SURGICAL TRENGUARD; TABLE AND ATTACHMENTS, OPERATING-ROOM Back to Search Results
Catalog Number 55201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hair Loss (1877); Head Injury (1879); Headache (1880)
Event Date 09/28/2018
Event Type  malfunction  
Event Description
A patient complained of a headache after their procedure and had a bump on her head.The patient was given an ice pack to put on her head and appeared to be ok.Patient was discharged home.Patient then contacted hospital to say she had developed a scab on the top of her head.Roughly a week after the procedure, patient had minimal hair loss at the top of the head.Three weeks after the procedure the patient displayed significant hair loss at the top of the head.As of last month, the patient's hair has not regrown.
 
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Brand Name
TRENGUARD
Type of Device
TABLE AND ATTACHMENTS, OPERATING-ROOM
Manufacturer (Section D)
DAN ALLEN SURGICAL
12373 kinsman rd.
building c suites 1 - 9
newbury OH 44065
MDR Report Key8554531
MDR Text Key143239539
Report Number8554531
Device Sequence Number1
Product Code BWN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/13/2019,03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number55201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2019
Event Location Hospital
Date Report to Manufacturer04/26/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age16425 DA
Patient Weight76
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