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Catalog Number PMM3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Inflammation (1932); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 08/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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, 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.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.Date of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications.Date - time of onset of mass, abscess, and pruritus from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-operation or intra-operation? were cultures performed? results? what were the results of the medical intervention performed with incision drainage and antibiotics administered? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
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Event Description
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It was reported that a patient underwent a tension free repair of right oblique hernia procedure on an unknown date in 2022 and the mesh was implanted.Post-op inflammation was reported.It was reported that on the 15th day after the surgery, a palpable mass with a size of about 9.3cm appeared at the incision of the right inguinal area.It was red, swollen, hard, tender, accompanied by pruritus.It was reported that the mass gradually increased.It was also reported that after admission, relevant examinations were completed, abdominal wall abscess incision drainage was performed, and levofloxacin injection 0.5g was given intravenously.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 09/27/2022.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, 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.H6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: date of initial surgical procedure? --(b)(6) 2022.The diagnosis and indication for the initial surgical procedure?--right indirect inguinal hernia.Other relevant patient history/concomitant medication.-unk.Date - time of onset of mass, abscess, and pruritus from the surgical procedure?--(b)(6) 2022, about half a month post-operation.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure?--no.Did the patient receive any prophylactic antibiotics pre-operation or intra-operation?--unk.Were cultures performed? results?--unk.What were the results of the medical intervention performed with incision drainage and antibiotics administered?--unk.What is physician¿s opinion as to the etiology of or contributing factors to this event?--physician believes infectious factors are related to the patch.What is the patient's current status?--patient has been discharged.
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Search Alerts/Recalls
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