MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COLLAMEND FM; PORCINE SURGICAL MESH

Catalog Number	1175115
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Erosion (1750); Hematoma (1884); Sepsis (2067); Hernia (2240)
Date of Event	06/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to a post-op complication.Per medical records review, post implant of collamend fm mesh, the patient was diagnosed with hematoma, abscess, erosion, wound dehiscence, hernia recurrence and sepsis.Note the medical records note that "features of sepsis due to previous stercoral perforation." the relationship between the sepsis and the implant are unclear; however it appears the sepsis diagnosis is not related to the mesh implant.Hernia recurrence and hematoma formation are known inherent risks of surgery/use of the device.The instructions-for-use supplied with the device lists hematoma and hernia recurrence as possible complications.The warning section states, "if the collamend fm implant is used in a contaminated or an infected site this may lead to premature weakening or breakdown of the implant." to date there have been no other reported complaints for this lot number.This mdr represents the collamend fm (device #1).An additional supplemental mdr was submitted to represent the ventralight st (device #2).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.
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2014 - patient was diagnosed with incisional hernia and parastomal hernia thereby underwent open repair with the implant of collamend fm mesh (device #1).Per operative notes, ¿adhesions were taken down.Collamend fm mesh is inserted directly and sutured.¿ (b)(6) 2014 to (b)(6) 2018 - during multiple visits patient had abdominal pain, hematoma, abscess, recurrent incisional hernia and became unwell with features of sepsis due to previous stercoral perforation with presence of erythema.(b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open abdominal wall reconstruction with the implant of ventralight st (device #2) and partial explant of collamend fm (device #1).Per operative notes, ¿hernia sac was identified.The old mesh (device #1) was released whereas not able to remove all the mesh.A ventralight st mesh (device #2) was placed and sutured in a sublay position.¿ (b)(6) 2018 to (b)(6) 2022 - during multiple visits patient had abdominal pain, wound dehiscence, skin lesion just lateral to previous abdominal scar, purulent discharge from wound sinus, sepsis and had eroding mesh.This file represents collamend fm mesh (device #1).
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to a post-op complication.Per medical records review, post implant of collamend fm mesh, the patient was diagnosed with hematoma, abscess, erosion, wound dehiscence, hernia recurrence and sepsis.Note the medical records note that "features of sepsis due to previous stercoral perforation." the relationship between the sepsis and the implant are unclear; however it appears the sepsis diagnosis is not related to the mesh implant.Hernia recurrence and hematoma formation are known inherent risks of surgery/use of the device.The instructions-for-use supplied with the device lists hematoma and hernia recurrence as possible complications.The warning section states, "if the collamend fm implant is used in a contaminated or an infected site this may lead to premature weakening or breakdown of the implant." to date there have been no other reported complaints for this lot number.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to the post-op complication.Updated fields: this supplemental mdr represents the collamend fm (device #1).An additional supplemental mdr was submitted to represent the ventralight st (device #2).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.
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2014 - patient was diagnosed with incisional hernia and parastomal hernia thereby underwent open repair with the implant of collamend fm mesh (device #1).Per operative notes, ¿adhesions were taken down.Collamend fm mesh is inserted directly and sutured.¿ on (b)(6) 2014 to (b)(6) 2018 - during multiple visits patient had abdominal pain, hematoma, abscess, recurrent incisional hernia and became unwell with features of sepsis due to previous stercoral perforation with presence of erythema.On (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open abdominal wall reconstruction with the implant of ventralight st (device #2) and partial explant of collamend fm (device #1).Per operative notes, ¿hernia sac was identified.The old mesh (device #1) was released whereas not able to remove all the mesh.A ventralight st mesh (device #2) was placed and sutured in a sublay position.¿ on (b)(6) 2018 to (b)(6) 2022 - during multiple visits patient had abdominal pain, wound dehiscence, skin lesion just lateral to previous abdominal scar, purulent discharge from wound sinus, sepsis and had eroding mesh.Addendum per information provided by patient's attorney: on (b)(6) 2022 - patient underwent drainage of abdominal wall abscess.This file represents collamend fm mesh (device #1).

• Brand Name: COLLAMEND FM
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 20081385
• Report Number: 1213643-2024-00426
• Device Sequence Number: 12715375
• Product Code: FTM
• UDI-Device Identifier: 00801741010590
• UDI-Public: (01)00801741010590(17)141028(10)DAXE0009
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 10/28/2014
• Device Catalogue Number: 1175115
• Device Lot Number: DAXE0009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 90 KG