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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH Back to Search Results
Model Number 5959812
Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Unspecified Infection (1930); Hernia (2240); Disability (2371)
Event Date 05/08/2012
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. The information provided alleges the patient experienced pain, inflammation, adhesions, abscess and infection. While there is no indication that the adhesions were directly related to the sepramesh, adhesions and inflammation are both listed as known possible adverse reactions in the instructions-for-use. In regards to the allegation of infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ with the current information available, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2008 - the patient underwent surgery for repair of an incisional hernia. A sepramesh ip mesh was implanted to repair the hernia defect. On (b)(6) 2012 - it was alleged that the device subsequently folded over, became entwined with his bowel, caused a severe inflammatory response, infection and abscess. Among other treatment, the patient underwent additional surgery to remove the malfunctioning device, take down adhesions and evacuate the abscess associated with the device. The attorney alleges the patient was injured severely and permanently and has suffered and will continue to suffer physical pain.
 
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Brand NameSEPRAMESH IP
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED 3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key6956394
MDR Text Key89567186
Report Number1213643-2017-00690
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063739
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,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2009
Device Model Number5959812
Device Catalogue Number5959812
Device Lot NumberWBSAS014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
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: 10/17/2017 Patient Sequence Number: 1
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