Model Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
Laceration(s) (1946)
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Event Date 10/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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On 11/12/2020 - we have requeted the device be returned to the manufacturer for an investigation.To date, we have not recieved the device.
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Event Description
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On 11/10/2020 - the consumer alleges that the product shattered in the bathroom.The consumer had a laceration as a result.
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Manufacturer Narrative
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11/12/2020: we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.4/27/2021: per the fda's request, submitted a supplemental mdr that does not include the age and dob.I also noticed the common device name and product code was incorrect.I made the change from a heating pad (irt) to a bmi scale (mnw).
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Event Description
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On (b)(6) 2020: the consumer alleges that the product shattered in the bathroom.The consumer had a laceration as a result.4/27/2021: per the fda's request, submitted a supplemental mdr that does not include the age and dob.
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Search Alerts/Recalls
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