MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO; SURGICAL MESH

Catalog Number UNKAA087

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Burning Sensation (2146); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Based on the information as it was reported it is unclear if the patient has undergone surgical intervention regarding this mesh, additionally it is unclear if the patient has been implanted with more than one device.The maude event report did not include any contact information for the reporter; therefore no attempts for additional information can be made at this time.Based on the information obtained from the report, we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged.Should additional information be provided, a supplemental mdr will be submitted.Without a lot number a review of the manufacturing records is not possible.The information provided by bard 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 bard.Not provided.

Event Description

The following, in summary was reported via maude event report (mw5071857): "mesh put in 2016.No problems with it till month 5 when mesh start shrinking significantly.This is the 2nd time i'm having this removed! i had this put in laparoscopically and this mesh has continued to shrink significantly while it's done this over the rectus muscle.The mesh continues to shrink on the rectus muscle and strangulates everything under this mesh, try to endure this pain.I had no pain first 5 months but when you have to feel mesh strangulate on your muscle as you watch feeling in legs worsen from pain/burning/numbing to complete numbness and pain 24/7.".

• Brand Name: VENTRALIGHT ST W/ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6896732
• MDR Text Key: 87448407
• Report Number: 1213643-2017-00632
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability