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Model Number PMII |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Depression (2361)
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Event Date 01/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? 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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It was reported that a patient underwent an unknown procedure on (b)(6) 2017 and the mesh was implanted.It was reported that the patient had a severe reaction to ethicon prolene hernia mesh.It was reported that the patient had four months not being able move, basically bedridden with excruciating pain.It was also reported that the patient had to fly to (b)(6) to get her mesh removed plus had to endure on going surgeries and still suffer chronic pain.It was also reported that patient outcome/consequences involved multiple surgeries, pain management, depression, and quality of life affected.
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Search Alerts/Recalls
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