Catalog Number UNK KELLER FUNNEL2 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: n/a backup device was used for operation.
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Event Description
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Healthcare professional reported "hair on the device" (keller funnel).No further information was provided.Device can't be implanted as it is used to implant breast implants.
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Manufacturer Narrative
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Clarification to d.4: lot number: 21b02c, expiration date: 10/feb/2023.Clarification to h.4: manufacturing date: 10/feb/2021.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
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Event Description
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Healthcare professional reported "hair on the device" (keller funnel).No further information was provided.Device can't be implanted as it is used to implant breast implants.
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Manufacturer Narrative
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Further investigation: the reported complaint of hair/fiber on device is confirmed since a hair/ fiber was observed within the funnel.It is unknown how the hair/ fiber came in contact with the funnel; however, the funnel was removed from the sterile tyvek pouch and trimmed/ manipulated prior to lake county sample receipt; therefore, handling cannot be ruled out.
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Event Description
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Healthcare professional reported "hair on the device" (keller funnel).No further information was provided.Device can't be implanted as it is used to implant breast implants.
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Search Alerts/Recalls
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