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Model Number N/A |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient experienced an allergic reaction while she was treating with the bone healing system.The patient stated that she has a copper allergy.The patient¿s bhs controller and coil make her foot swell up and cause discomfort.It was later reported on (b)(6) 2022, that the patient confirmed the coil used was a slfx coilette.The patient further advised she had a full body allergic reaction to the bhs.The skin on her whole body was itchy.The patient did not experience redness, blisters, welts, no other skin issues, or pain.The patient was advised by her physician to discontinue treatment with the bone healing system, and she would be switched to an ortho pak assembly.No additional patient consequences have been reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The device not was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with allergic reaction, swelling, and discomfort.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.
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Event Description
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It was reported that the patient experienced an allergic reaction while she was treating with the bone healing system.The patient stated that she has a copper allergy.The patient¿s bhs controller and coil make her foot swell up and cause discomfort.It was later reported on aug 5, 2022, that the patient confirmed the coil used was a slfx coilette.The patient further advised she had a full-body allergic reaction to the bhs.The skin on her whole body was itchy.The patient did not experience redness, blisters, welts, no other skin issues, or pain.The patient was advised by her physician to discontinue treatment with the bone healing system, and she would be switched to an ortho pak assembly.No additional patient consequences have been reported.
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Search Alerts/Recalls
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