Catalog Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hernia (2240); Injury (2348); Hypoesthesia (2352); Not Applicable (3189)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
|
|
Event Description
|
It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2012 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
|
|
Manufacturer Narrative
|
Patient code: 3189-surgical intervention.It was reported that following the procedure the patient experienced numbness in the belly.It was also reported that the patient underwent mesh removal with new implant on (b)(6) 2018 due to recurrent ventral incisional hernia.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
|
|
Search Alerts/Recalls
|