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

Catalog Number UNKAA013

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made regarding the bard/davol collamend (device #2) used to treat the patient.The patient's attorney alleged medical consultations and injuries, however; no details have been provided regarding the nature of the injury.No lot number has been provided; therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol collamend (device #2).An additional emdr was submitted to represent the bard/davol composix mesh (device #1).Not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol composix mesh (device #1).(b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol collamend (device #2).(b)(6): the patient ad unspecified injuries, including consultations with medical providers.The patient is making a claim for an adverse patient outcome against the composix mesh (device #1) and collamend (device #2).The patient's 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.".

• Brand Name: COLLAMEND
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): MEDCHEM PRODUCTS, INC. -1223089; 160 new boston street; woburn MA 01801
• Manufacturer Contact: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 8130653
• MDR Text Key: 129253195
• Report Number: 1213643-2018-04375
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• 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