The product involved in the event has not been received but a sample is anticipated from the reporter for evaluation.Patient 1 of 3.Iowa specialty hospital reported patient surgical infection(s).The hospital has not identified the reported lumbar decompression kit is the source; however, it is one of the devices which was utilized during procedure(s).Additional information was received on (b)(6) 2022 that states, there was a total of three packs used during surgery with the same lot number (843221).This occurred with three different patients that developed infections.All information reasonably known as of (b)(6) 2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
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Patient 1 of 3.Iowa specialty hospital reported patient surgical infection(s).The hospital has not identified the reported lumbar decompression kit is the source; however, it is one of the devices which was utilized during procedure(s).Additional information was received on (b)(6) 2022 that states, there was a total of three packs used during surgery with the same lot number (843221).This occurred with three different patients that developed infections.
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The product involved in the event was not returned for evaluation."after a thorough investigation with the team, including process, system, records, and evaluation, no immediate cause could be identified, that would have caused or contributed to the reported incident.It is noteworthy that the complainant identified an infection; therefore, as part of the investigation, would include a request for the tray supplier to conduct an internal investigation." all information reasonably known as of 28sep2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to (b)(6), in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
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