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Catalog Number PROMESHUNK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Seroma (2069); Ambulation Difficulties (2544)
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Event Date 04/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the 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 so, please provide your surgeon¿s name, contact information and sign release of medical information form.
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Event Description
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It was reported that the patient underwent an abdominal hernia repair procedure on unknown date and the mesh was implanted.The patient experienced complications include chronic abdominal, pubic and groin pain, pain in lower back, both hips and buttocks and leg pain associated with difficulty in walking, standing and sitting.The patient experienced sensation of incomplete bladder emptying and difficulty in passing urine.It was also reported that the patient experienced loss of appetite, weight loss and 5 stone.The patient is unable to move without tearing/burning sensation in abdomen and experiencing extreme sensitivity on skin area around wound site.Per patient, they experienced a pain in right arm and left leg.Seroma around wound site was aspirated once but returned.The patient is also unable to use the toilet without having to use movicol and experiencing irritable bowel.Additional information has been requested.
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Search Alerts/Recalls
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