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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1161520
Device Problem Insufficient Information (3190)
Patient Problems Anaphylactic Shock (1703); Reaction (2414)
Event Date 01/06/2016
Event Type  Injury  
Manufacturer Narrative
The surgeon provided information about the patient who had a complex medical history, whose condition was compromised at the time of surgery and was not in good health. The doctor reported the patient had no known allergy to porcine. The ifu states "an allergic reaction, which is unrelated to other therapy, is an indication to consider removal of the xenmatrix surgical graft. " the infection that presented after the implant was not associated to the use of the product. However, regarding infection the ifu warns "if an infection develops, it should be aggressively treated. " patient has a complex medical history and there is no connection that can be made at this time between the post-op complications experienced and the use of xenmatrix to treat the wound. At this time no conclusions can be made. If additional information is obtained, a supplemental mdr will be submitted. Four additional mdr's are filed to document the other xenmatrix grafts implanted on (b)(6) 2016 the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that a patient who was treated with xenmatrix experienced an anaphylactic shock type response after implant. The patient who had been hospitalized for an extended period of time with a non-healing wound was brought to the or to have the abdominal wound bridged. This was a very large area 70cm x 60cm and the surgeon used five pieces of xenmatrix graft and a wound vac was placed. It was reported the patient experienced a large bowel movement and fibrillation when moving from the or and required resuscitation. The patient was stabilized. Within 24 hours patient mounted a wbc count of >30 with a large bandemia, he developed v-fib and received aicd shock. It was reported that a post operative infection was present. Patient had erosion and breakdown of the previously placed feeding jejunostomy. Patient was returned to or for washout, removal of jejunostomy, additional mesh fixation and wound vac therapy. Treatment included the removal of an eroded section of xenmatrix graft material. The xenmatrix grafts were left implanted. The surgeon could not confirm the cause of the post op events. This was reported to be her first use of xenmatrix and she had concern that the large about of graft used to bridge the defect could have contributed to the problem. She indicated that he had no other reactive type response to the material.
 
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Brand NameXENMATRIX
Type of DevicePORCINE SURGICAL 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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5410201
MDR Text Key37461234
Report Number1213643-2016-00041
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K081272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2017
Device Catalogue Number1161520
Device Lot NumberHUZA1120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2015
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: 02/04/2016 Patient Sequence Number: 1
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