MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number	0115322
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Disability (2371)
Date of Event	11/29/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient underwent an additional surgery to remove the 3dmax after being admitted to the hospital exhibiting symptoms including nausea, persistent vomiting, abdominal pain, and an abdominal mass.The explanting surgeon noted "lots of adhesions" and abscess fluid.The 3dmax was described as "floating inside." medical records are not available at this time.Adhesions are a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ should additional information be provided a supplemental emdr will be submitted.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.Device not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2003: the patient underwent surgery for repair of a right inguinal hernia.A bard/davol 3dmax, reference number 0115322, lot number 41fmdd04 was implanted to repair the hernia defect.(b)(6) 2014: the patient underwent an additional surgery to remove the 3dmax after being admitted to the hospital exhibiting symptoms including nausea, persistent vomiting, abdominal pain, and an abdominal mass.As reported, the explanting surgeon noted "lots of adhesions" and abscess fluid and the 3dmax was described as "floating inside." as alleged, the patient was injured severely and permanently and has suffered an will continue to suffer physical pain due to the alleged defective 3dmax.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2003: the patient underwent surgery for repair of a right inguinal hernia.A bard/davol 3dmax, reference number 0115322, lot number 41fmdd04 was implanted to repair the hernia defect.(b)(6) 2014: the patient underwent an additional surgery to remove the 3dmax after being admitted to the hospital exhibiting symptoms including nausea, persistent vomiting, abdominal pain, and an abdominal mass.As reported, the explanting surgeon noted "lots of adhesions" and abscess fluid and the 3dmax was described as "floating inside." as alleged, the patient was injured severely and permanently and has suffered an will continue to suffer physical pain due to the alleged defective 3dmax.
Additional Manufacturer Narrative
Addendum to the previous information.This supplemental emdr is being sent to provide the correct lot number for the 3dmax device.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2003: the patient underwent surgery for repair of a right inguinal hernia.A bard/davol 3dmax, reference number 0115322, lot number 41fmdd04 was implanted to repair the hernia defect.(b)(6) 2014: the patient underwent an additional surgery to remove the 3dmax after being admitted to the hospital exhibiting symptoms including nausea, persistent vomiting, abdominal pain, and an abdominal mass.As reported, the explanting surgeon noted "lots of adhesions" and abscess fluid and the 3dmax was described as "floating inside." as alleged, the patient was injured severely and permanently and has suffered an will continue to suffer physical pain due to the alleged defective 3dmax.Addendum per additional information provided: (b)(6) 2003 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax.Per operative notes, ¿patient has a pantaloon hernia which includes a direct and indirect component.A 3dmax mesh is inserted into the preperitoneal space, deployed in the inguinal region, and stapled in place with a protack instrument.¿ (b)(6) 2014 - patient had abdominal pain and intra-abdominal abscess.(b)(6) 2014 - patient was diagnosed with cystic mass on right abdominal cavity and abscess cavity of right lower abdominal area with infected graft thereby underwent removal of mesh.Per operative notes, ¿adhesions were taken down, then the mass was identified and was separated from the intestines.The drainage of all the abscess and the graft floating inside was also removed.¿ attorney alleges that the patient had abscess, infection, pain, hernia recurrence, inflammatory cell infiltration, hemorrhage and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient underwent an additional surgery to remove the 3dmax after being admitted to the hospital exhibiting symptoms including nausea, persistent vomiting, abdominal pain, and an abdominal mass.The explanting surgeon noted "lots of adhesions" and abscess fluid.The 3dmax was described as "floating inside." medical records are not available at this time.Adhesions are a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ addendum #1: h11: addendum to the previous information.This supplemental emdr is being sent to provide the correct lot number for the 3dmax device.Addendum #2: h11: this supplemental emdr is submitted to document additional information provided and to correct the expiry date, pma/510(k) and manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 11 years 9 months post implant of 3dmax, patient was diagnosed with infection, inflammation, adhesions, abscess and abdominal pain thereby underwent mesh removal.The instructions-for-use supplied with the device list inflammation as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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.

• Brand Name: 3DMAX
• 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: 7289989
• Report Number: 1213643-2018-00353
• Device Sequence Number: 19331219
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772(17)050628(10)41FMDD04
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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: 06/28/2005
• Device Catalogue Number: 0115322
• Device Lot Number: 41FMDD04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 10/01/2024
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 10/24/2018; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2002
• 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: Hospitalization; Disability; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 82 KG