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Catalog Number A2414T |
Device Problems
Break (1069); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).The hospital never reported the previous cases.In fact, they said that the doctor only reported it to them now, because he noticed that the suture still has the same problem.Therefore, we do not know how many times there were previously device return status: there is no sample to be analyzed.Doctors discarded it.The following information was requested, but unavailable: did the event occur during one or multiple patient procedures? what is the total number of procedures? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.Did the suture package contained the expected tubing fluid 2.Was the suture package dry? 3.What tissue was being approximated/ sutured? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-05453.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Doctor informed that catgut 2-0 is breaking and coming with little fluid (tonsils).During suturing, the thread unraveled and tangled several times and finally broke several times.This thread has been dry, despite the liquid that comes in the package.Customer reference/po/service hospital (b)(6), patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (b)(4).Device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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Manufacturer Narrative
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Product complaint (b)(4).Date sent to the fda: 8/8/2022.H6 component code: g07002 no device returned.Additional information was received: as i pointed out in the attachment on the day (b)(6) 2022 11:21), the hospital never reported the previous cases.In fact, they said that the doctor only reported it to them now/at the same time that we also received the complaint ¿ this is because he realized that the thread still has the same problem.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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