|
Catalog Number 0112750 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Pain (1994); Hernia (2240)
|
Event Date 04/01/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on the information provided, no conclusions can be made.As reported, patient experienced pain and hernia recurrence about 7 years post-implant of the perfix plug.Based on the information obtained, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use supplied with the device as a possible complication.Note, the date of event is considered to be a best estimate as (b)(6) 2015 based on the information provided.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Not returned - remains implanted.
|
|
Event Description
|
As reported, the patient underwent an inguinal hernia repair surgery on (b)(6) 2015 with implant of a bard/davol perfix plug and had been experiencing ongoing pain for a long time.As reported, the patient underwent an ultrasound, which noted a wall defect and hernia recurrence.
|
|
Event Description
|
As reported, the patient underwent an inguinal hernia repair surgery on (b)(6) 2015 with implant of a bard/davol perfix plug and had been experiencing ongoing pain for a long time.As reported, the patient underwent an ultrasound, which noted a wall defect and hernia recurrence.
|
|
Manufacturer Narrative
|
Based on the information provided, no conclusions can be made.As reported, patient experienced pain and hernia recurrence about 7 years post-implant of the perfix plug.Based on the information obtained, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use supplied with the device as a possible complication.Note, the date of event is considered to be a best estimate as 01-apr-2015 based on the information provided.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the corrected expiry date and dhr review results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in january, 2015.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Search Alerts/Recalls
|
|
|