VICKS V912US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for VICKS V912US manufactured by Onbo Electronic(shenzhen) Co.,ltd,.

Event Text Entries

[139686375] Preliminary investigation, (b)(4) pcs v912 us have been fully checked, no loose battery lid are found. By checking our internal quality records, no loose battery were found. Based on the standard of iec60601-1-11,8. 5. 2, evaluation of battery cover design, 2 pcs have passed the third-party evaluation. Since the year of 2006, total of (b)(4) pcs v912 had been distributed into market, so far this is the only case reported. No battery cover loose nonconformity found in onbo production and during kaz pre-shipment inspection.
Patient Sequence No: 1, Text Type: N, H10


[139686376] On (b)(6) 2019 (b)(6)'s son somehow got the cover off the unit of v912usv1, and he got the battery out and ate the battery; after the battery was removed by surgery the damage to esophagus has been done, the battery had burned 40% of his esophagus, and he is scheduled for more surgeries over the next months. Below is the original email description,from which we got this complaint information: son is in icu now. Child ate battery. Child is (b)(6). Incident happened on (b)(6). Had life flight to surgery. Has electrical burns on esophagus. Does not have lot code. (b)(6) 03/1/19. Has a (b)(6) son, he got the battery out the thermometer and now he`s on life support, he was life supported to hospital on (b)(6) 2019, what happened is she put him down to get his breakfast ready and all of a sudden he started screaming crying, she couldn`t find anything wrong with him externally, she started to bathe him to calm him down, it did not work, he started drooling profusely, he does have a disorder, he`s hungry 24/7 and was chewing on thermometer, she brought him to er, they checked for many things then did x-ray, dr come into room while we were talking, she put me on hold for a bit and asked if she can call me back, provided my direct # and verified hers in case i don`t hear from her or if i miss her call. I`ll call her back. (b)(6) 03/01/19: ob call, 12:29 pm: the x-ray showed that at the bottom of the esophagus was the battery, in their town they don`t have a pediatrician or a pediatrician in the er so they were life flighted 35 hours away, he then had surgery to remove battery but damage has been done, the battery burned 40% of his esophagus, he did this within a half hour and somehow he got that opened, the cover was on the unit but somehow got the cover off and he got the battery out and ate the battery. She has the unit but it`s back at her house 3. 5 hours away, can`t provide date code. Bought in (b)(6) 2018 at (b)(6) in (b)(6). He`s had two more surgeries the day before yesterday (b)(6) 2019, she has pictures that she can share of the injury. He is scheduled for more surgeries over the next few months.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680225-2019-00001
MDR Report Key8444063
Date Received2019-03-22
Date of Report2019-03-22
Date of Event2019-02-24
Date Added to Maude2019-03-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR GARY HUANG
Manufacturer StreetNO.497, TA LANEG NAN ROAD, TA LANEG STREET, BAOAN DISTRIC
Manufacturer CitySHENZHEN,
Manufacturer CountryCH
Manufacturer G1ONBO ELECTRONIC (SHENZHEN) CO., LTD.
Manufacturer StreetNO.497, TA LANEG NAN ROAD, TA LANEG STREET, BAOAN DISTRIC
Manufacturer CitySHENZHEN,
Manufacturer CountryCH
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVICKS
Generic NameV912US (V912BBUS)
Product CodeFLL
Date Received2019-03-22
Model NumberV912US
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerONBO ELECTRONIC(SHENZHEN) CO.,LTD,
Manufacturer AddressNO.497, TA LANEG NAN ROAD, A LANEG STREET, BAOAN DISTRICT SHENZHEN, CH


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2019-03-22

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