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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. ".
 
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Brand NameCOLLAMEND
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
MEDCHEM PRODUCTS, INC. -1223089
160 new boston street
lot #1, road #3, km 79.7
woburn MA 01801
Manufacturer Contact
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key8518960
MDR Text Key142098511
Report Number1213643-2019-03051
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
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
Device Catalogue NumberUNKAA013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2019
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 Treatment Data
Date Received: 04/16/2019 Patient Sequence Number: 1
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