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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYMAX CORP. -2523003 SITE-RITE PREVUE PLUS SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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DYMAX CORP. -2523003 SITE-RITE PREVUE PLUS SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770086
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Burning Sensation (2146)
Event Type  Injury  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the reported issue of electrical shock from probe is inconclusive as neither the clinical setting nor the reported issue could be duplicated during evaluation. Visual inspection of the probe handle, nose area, and lens did not reveal any indications that there was a high voltage spike from the probe and the results of patient leakage testing are within specifications. Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device. The returned system did not display the behavior reported by the complainant and it is likely that the event was caused by another root cause. A history review of serial number dybsq505 showed no other similar complaint(s) from this serial number.
 
Event Description
Per biomed it was reported that during a recent procedure, a patient said that the prevue probe caused a stinging feeling on her skin. She said that it felt like "pins and needles" on her skin. The prevue was plugged into ac power at the time of the procedure. Biomed mentioned that an electrical safety was done on the system previously. Biomed also mentioned that the system doesn't look to have any damage to it and the ac adapter doesn't have any damage to it.
 
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Per biomed it was reported that during a recent procedure, a patient said that the prevue probe caused a stinging feeling on her skin. She said that it felt like "pins and needles" on her skin. The prevue was plugged into ac power at the time of the procedure. Biomed mentioned that an electrical safety was done on the system previously. Biomed also mentioned that the system doesn't look to have any damage to it and the ac adapter doesn't have any damage to it.
 
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Brand NameSITE-RITE PREVUE PLUS
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7138889
MDR Text Key192872159
Report Number3006260740-2017-02290
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number9770086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/21/2018
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

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