Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that the customer mentioned about the negative effects of the adhesive of statlock.The customer indicated that alcohol wipes are required to remove statlock from the skin and usually lot of alcohol is required to remove it sufficiently.This dries out the skin which leads to higher risk of getting medical adhesive-related skin injuries.This was a general comment and it was not from a specific patient.
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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.
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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 ¿process error".It was unknown whether the device had met 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 customer mentioned about the negative effects of the adhesive of statlock.The customer indicated that alcohol wipes are required to remove statlock from the skin and usually lot of alcohol is required to remove it sufficiently.This dries out the skin which leads to higher risk of getting medical adhesive-related skin injuries.This was a general comment and it was not from a specific patient.
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Search Alerts/Recalls
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