MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH; SURGICAL MESH

Catalog Number	0117016
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Inflammation (1932); Seroma (2069); Swelling/ Edema (4577)
Date of Event	03/03/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with the implant of ventralex st mesh (device #1).Per operative notes, ¿the sac was incised.A small ventralex st mesh (device #1) was used into the extraperitoneal spaced and sutured.¿ (b)(6) 2013 to (b)(6) 2013 - patient was diagnosed with incomplete primary healing and fluid accumulation.(b)(6) 2013 to (b)(6) 2013 - patient was diagnosed with wound infection thereby underwent wound care.(b)(6) 2013 - patient was diagnosed with non-healing umbilical wound and infected mesh thereby underwent open repair with the implant of absorbable mesh and explant of ventralex st mesh (device #1).Per operative notes, ¿the mesh products and sutures were carefully dissected and removed.The resulting defect was palpated.There was so adherent small bowel.This was closed with a double layer of absorbable mesh and sutured.¿ (b)(6) 2013 - patient underwent hiatal hernia repair thereby underwent placement of ap standard lap-band with e2 port.Per operative notes, ¿the hernia defect was identified.The defect was closed using an endostitch device by approximating right crura to the left crura.The ap standard lap-band was then flushed and placed in the abdominal cavity and sutured.¿ (b)(6) 2014 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of two bard soft mesh (device #2 & #3).Per operative notes, ¿a large defect identified in the umbilical midline after dissecting the large sac.A large bard soft mesh (device #1) was cut into size and sutured.The mesh was tailored to be little wrinkling and all the lateral edges were sutured.Also, the fascial edges were approximated with another layer of bard soft mesh (device #2) and sutured.¿ (b)(6) 2014 - patient was diagnosed with seroma thereby underwent wound drainage.(b)(6) 2014 - patient was diagnosed with abdominal wall abscess thereby underwent incision and drainage of abdominal wall abscess.Per operative notes, ¿entire abscess drainage was accomplished.Debridement with gauze and finger dissection and removal of all necrotic material was done and the entire area was packed with kerlix gauze filled with saline and dry dressings applied over it.Attorney alleges that the patient had abscess, infection, pain and hernia recurrence.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 1 month post implant of bard soft mesh, patient was diagnosed with inflammation, swelling, seroma and abscess thereby underwent wound drainage.The instructions-for-use supplied with the device lists inflammation and seroma as possible complications.This emdr represents bard soft mesh (device #2).An additional supplemental emdr has been submitted to represent ventralex st (device #1) and an emdr was submitted to represent bard soft mesh (device #3).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.H3 other text: not returned,.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 1 month post implant of bard soft mesh, patient was diagnosed with inflammation, swelling, seroma and abscess thereby underwent wound drainage.The instructions-for-use supplied with the device lists inflammation and seroma as possible complications.Addendum: h11: this supplemental emdr is submitted to update manufacturing date and to correct patient id and event description.Review of manufacturing records confirms product was manufactured to specification.Updated fields: b4, g3, g6, h2, h4 (manufacturing date), h6, h10, h11.Corrected fields: a1 (patient id), b5 (event description).This supplemental emdr represents bard soft mesh (device #2).Additional supplemental emdr's were submitted to represent ventralex st (device #1) and bard soft mesh (device #3).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.H3 other text: not returned.
Event or Problem Description
Per additional information provided: on (b)(6) 2013 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with the implant of ventralex st mesh (device #1).Per operative notes, ¿the sac was incised.A small ventralex st mesh (device #1) was used into the extraperitoneal spaced and sutured.¿ on (b)(6) 2013 - patient was diagnosed with incomplete primary healing and fluid accumulation.On (b)(6) 2013 - patient was diagnosed with wound infection thereby underwent wound care.On (b)(6) 2013 - patient was diagnosed with non-healing umbilical wound and infected mesh thereby underwent open repair with the implant of absorbable mesh and explant of ventralex st mesh (device #1).Per operative notes, ¿the mesh products and sutures were carefully dissected and removed.The resulting defect was palpated.There was so adherent small bowel.This was closed with a double layer of absorbable mesh and sutured.¿ on (b)(6) 2013 - patient underwent hiatal hernia repair thereby underwent placement of ap standard lap-band with e2 port.Per operative notes, ¿the hernia defect was identified.The defect was closed using an endostitch device by approximating right crura to the left crura.The ap standard lap-band was then flushed and placed in the abdominal cavity and sutured.¿ on (b)(6) 2014 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of two bard soft mesh (device #2 & #3).Per operative notes, ¿a large defect identified in the umbilical midline after dissecting the large sac.A large bard soft mesh (device #2) was cut into size and sutured.The mesh was tailored to be little wrinkling and all the lateral edges were sutured.Also, the fascial edges were approximated with another layer of bard soft mesh (device #3) and sutured.¿ on (b)(6) 2014 - patient was diagnosed with seroma thereby underwent wound drainage.On (b)(6) 2014 - patient was diagnosed with abdominal wall abscess thereby underwent incision and drainage of abdominal wall abscess.Per operative notes, ¿entire abscess drainage was accomplished.Debridement with gauze and finger dissection and removal of all necrotic material was done and the entire area was packed with kerlix gauze filled with saline and dry dressings applied over it.Attorney alleges that the patient had abscess, infection, pain and hernia recurrence.

• Brand Name: BARD SOFT MESH
• Common Device Name: 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 20342649
• Report Number: 1213643-2024-094730
• Device Sequence Number: 7842189
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)181028(10)HUXJ0057
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 0117016
• Device Lot Number: HUXJ0057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 154 KG