MAUDE Adverse Event Report: ONBO ELECTRONIC(SHENZHEN) CO.,LTD, VICKS; V912US (V912BBUS)

Model Number	V912US
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	02/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: VICKS
• Common Device Name: V912US (V912BBUS)
• Manufacturer (Section D): ONBO ELECTRONIC(SHENZHEN) CO.,LTD,; no.497, ta laneg nan road,; a laneg street, baoan district; shenzhen, ; CH
• MDR Report Key: 8444063
• Report Number: 9680225-2019-00001
• Device Sequence Number: 2926100
• Product Code: FLL
• UDI-Device Identifier: 30328785000277
• UDI-Public: (01)30328785000277
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: V912US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 13 MO