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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COLLAMEND; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 COLLAMEND; SURGICAL MESH Back to Search Results
Catalog Number UNKAA013
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, no conclusions can be made.A lot number has not been provided; therefore, we are unable to review the manufacturing records of the lot in question.The information is limited at this time and medical records have not been provided.Should additional information be provided a supplemental emdr will be submitted.Not returned.
 
Event Description
It is alleged by the patient's attorney that the patient underwent surgery for the implant of an unspecified bard/davol collamend mesh on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the collamend mesh.The 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.".
 
Event Description
It is alleged by the patient's attorney that the patient underwent surgery for the implant of an unspecified bard/davol collamend mesh on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the collamend mesh.The 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.".
 
Manufacturer Narrative
Based on the information provided, no conclusions can be made.A lot number has not been provided; therefore, we are unable to review the manufacturing records of the lot in question.The information is limited at this time and medical records have not been provided.Should additional information be provided a supplemental emdr will be submitted.This is an addendum to the initial emdr to make a correction to the manufacturing site.
 
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Brand Name
COLLAMEND
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key8518960
MDR Text Key142098511
Report Number1213643-2019-03051
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K052322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKAA013
Was Device Available for Evaluation? No
Date Manufacturer Received05/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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