Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn(s) (1757)
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Event Date 04/13/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had on arctic gel pads and had an mri.After the mri was done the patient had bilateral burns in the scapula area requiring wound care.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd represents all 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 bd.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿improper consideration of end user requirements-pad geometry or materials interfere with treatments, monitoring, imaging or other diagnostic procedures".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - 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.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient had on arctic gel pads and had an mri.After the mri was done the patient had bilateral burns in the scapula area requiring wound care.Per follow up information received via email on 24may2023, it was reported that the patient had on arctic gel pads and had an mri.After the mri was done the patient had bilateral burns in the scapula area requiring wound care.
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Search Alerts/Recalls
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