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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 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
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. ".
 
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Brand NameCOLLAMEND
Type of DeviceSURGICAL 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 Key8130653
MDR Text Key129253195
Report Number1213643-2018-04375
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 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 Received12/04/2018
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 Received11/16/2018
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 Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
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