Catalog Number 11349 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Scar Tissue (2060); Skin Discoloration (2074); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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On (b)(6) 2022, it was reported that a (b)(6) male patient experienced an increase in scarring after an achille & peroneal procedure.The patient required a revision procedure on an unspecified date to remove the excess scar tissue on the tendon that was in contact with the 2mm suture tape.Discoloration at the incision site was also reported.No medical history provided.No concomitant products reported.Date of the implant was (b)(6) 2021.Additional information was solicited.
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Manufacturer Narrative
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This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of additional information and or upon completion of the investigation by the manufacturing plant.
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Manufacturer Narrative
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This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of additional information and or upon completion of the investigation by the manufacturing plant.This case is one of 13 cases reported by the same physician.Additional information was solicited and not provided.There was no device malfunction or issues of appearance reported at the time of use.The current status of the patient is unknown.A batch record review was performed on this lot.There was no non conformances recorded in the manufacturing records.The lot was released for commercial use on 26aug2020.The expiration date is 29jul2025.Additionally, the supplier confirmed that there were no changes in the design or process of for manufacturing.There were no prior reports of complaints from other clinics.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.
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Event Description
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On 05may2022, it was reported that a 44 year old male patient experienced an increase in scarring after an achille & peroneal procedure.The patient required a revision procedure on an unspecified date to remove the excess scar tissue on the tendon that was in contact with the 2mm suture tape.Discoloration at the incision site was also reported.No medical history provided.No concomitant products reported.Date of the implant was (b)(6) 2021.Additional information was solicited.This case is one of 13 reported by the same clinic.
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Search Alerts/Recalls
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