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

Catalog Number UNKAA014

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  Injury  

Event Description

Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x and collamend fm on (b)(6) 2007 and/or (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against both the devices.Attorney also alleges that the patient sustained injuries on (b)(6) 2007, (b)(6) 2007, (b)(6) 2009 and (b)(6) 2009.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ it is also alleged that the patient experienced emotional distress and the device was defective.

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol collamend fm (device #2).An additional emdr was submitted to represent the bard/davol composix mesh e/x (device #1).Should additional information be provided, a supplemental emdr will be submitted.

• Brand Name: COLLAMEND FM
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. - 1223089; 160 new boston street; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 15842286
• MDR Text Key: 304096978
• Report Number: 1213643-2022-097207
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2022
• 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): Disability
• Patient Sex: Female