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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112780
Device Problems Defective Device (2588); Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Scarring (2061); Disability (2371)
Event Date 07/25/2017
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol perfix plug device may have caused or contributed to the reported event. To date no medical records have been provided. The attorney alleges the patient underwent an additional surgery for revision during which the bowel was injured. Another surgery was performed to remove the failed device, scarring and adhesions were noted. There was a ball of previous mesh overlying the tubercle which was cut free. Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. No sample has been returned for evaluation. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided a supplemental emdr will be submitted.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2003: the patient underwent right inguinal hernia repair. A bard/davol perfix plug was implanted in patient during this repair. On (b)(6) 2016: the patient underwent revision surgery. During the revision surgery, patient¿s bowel was injured. On (b)(6) 2017: the patient underwent removal of the failed perfix plug. The physician noted that ¿the hernia sac could not be reduced due to the large amount of scarring and previous mesh that was in place. There was a huge amount of adhesions and scarring in this area. So, it was very difficult to identify anatomy. There was a big ball of previous mesh overlying the tubercle. This was cut free. ¿ patient continues to experience complications related to the mesh. He will likely require additional surgeries to repair the damage from the mesh product. The mesh had to be surgically removed, necessitating further invasive surgery to repair the very issue that the product was intended to repair, and thus providing no benefit to him. The patient was caused to suffer severe personal injuries, pain and suffering and other damages. The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment.
 
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Brand NamePERFIX PLUG
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
roxanne tidwell
100 crossings blvd.
warwick, RI 02886
8015652659
MDR Report Key7986821
MDR Text Key124462770
Report Number1213643-2018-03640
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922916
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 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2007
Device Catalogue Number0112780
Device Lot Number43JMD410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2002
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: 10/19/2018 Patient Sequence Number: 1
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