Model Number AG606969A |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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Patient Problem
Full thickness (Third Degree) Burn (2696)
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Event Date 07/07/2022 |
Event Type
Injury
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Event Description
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Left posterior upper arm burned while using bodytite technology.
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Manufacturer Narrative
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Third-degree burn (full thickness) located in the postero-medial aspect of the left arm, approximately 3 x 2 cm in size.The event occurred in (b)(6) 2022 and is only now being reported.Following the use of the bodytite in various positions and in both supine and prone decubitus.The patient was subsequently treated with 5 sessions of laser over the scar area.The last documented follow-up session dates back to (b)(6) 2022 where the issue has not been resolved.Although at present the patient would in all likelihood have recovered and largely healed; however, not having the photos of the current state and in consideration of the entity of the event (third degree burn) it was decided to report the case to the competent authorities.
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Event Description
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Left posterior upper arm burn while using bodytite technology.
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Manufacturer Narrative
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Follow up 07/02/2023.1.Investigation conclusions : user error excluding technical failure and being the setting of parameters in accordance with the protocol, it is a question of a wrong maneuvering, approaching too close to the port of access and lingering too long while the energy was being supplied.Summary of related investigations: excess of energy in the surface area due to incorrect movement technique with the cannula.2.Medical device problem code - changed to 2017.3.Type of investigation - changed to 10.4.Investigation findings - changed to 4248.5.Investigation conclusions - changed to 61.6.Added section g1.
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Search Alerts/Recalls
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