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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH W/ ECHO; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH W/ ECHO; SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033); Reaction (2414)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
A sample mesh has been provided to the medical facility for reactivity testing, at this time it is unknown when/if the testing will be performed.Based on the information provided no conclusion can be made, as to what is causing the patient's reported reaction.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Allergic reaction is identified in the adverse reactions section of the instructions-for-use as a possible complication.Should additional information be provided a supplemental emdr will be submitted.Remains implanted.
 
Event Description
It was reported that following the implant of a bard ventralight st mesh the patient experienced a possible allergic reaction to the mesh.
 
Event Description
It was reported that following the implant of a bard ventralight st mesh the patient experienced a possible allergic reaction to the mesh.Addendum: (b)(6) 2019 the patient was implanted with a bard ventralight st mesh (w/echo ps) for ventral hernia repair.About an hour after the mesh was implanted and for an unusually long period of time, the patient experienced widespread itchy rash and hypotension.Patient was treated with a shot of adrenaline.Patient has no known allergies.
 
Manufacturer Narrative
A sample mesh has been provided to the medical facility for reactivity testing, at this time it is unknown when/if the testing will be performed.Based on the information provided no conclusion can be made, as to what is causing the patient's reported reaction.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Allergic reaction is identified in the adverse reactions section of the instructions-for-use as a possible complication.Should additional information be provided a supplemental emdr will be submitted.H11: this is an addendum to the initial emdr to document additional information provided.As reported there is no scheduled date for the testing and the contacts states "i don't predict we will be doing the testing anytime soon." as such the initial determination remains the same, no conclusion can be made, as to what is causing the patient's reported reaction.Updated fields: a2, b3, b4, b5, d6, g4, g7, h2, h4, h6, h11.Corrected fields: d1, d4, g5.Section a through f - the information provided by bd 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 bd.H3 other text : remains implanted.
 
Event Description
It was reported that following the implant of a bard ventralight st mesh the patient experienced a possible allergic reaction to the mesh.Addendum: (b)(6) 2019 - the patient was implanted with a bard ventralight st mesh (w/echo ps) for ventral hernia repair.About an hour after the mesh was implanted and for an unusually long period of time, the patient experienced widespread itchy rash and hypotension.Patient was treated with a shot of adrenaline.Patient has no known allergies.Addendum: it is reported that the patient underwent reactivity testing with a mesh sample provided.The patient tested negative for a mesh reaction.
 
Manufacturer Narrative
A sample mesh has been provided to the medical facility for reactivity testing, at this time it is unknown when/if the testing will be performed.Based on the information provided no conclusion can be made, as to what is causing the patient's reported reaction.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Allergic reaction is identified in the adverse reactions section of the instructions-for-use as a possible complication.Should additional information be provided a supplemental emdr will be submitted.This is an addendum to the initial emdr to document additional information provided.As reported there is no scheduled date for the testing and the contacts states "i don't predict we will be doing the testing anytime soon." as such the initial determination remains the same, no conclusion can be made, as to what is causing the patient's reported reaction.Updated fields: a2, b3, b4, b5, d6, g4, g7, h2, h4, h6 corrected fields: d1, d4, g5 this is an addendum to the previously submitted emdrs to document reactivity test results.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative condition does not appear to be caused by the bard/davol mesh used to treat the patient.Updated fields: b4, b5, g4, g7, h2, h6, h10.Note: section a through f - the information provided by bd 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 bd.H3 other text : remains implanted.
 
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Brand Name
VENTRALIGHT ST MESH W/ ECHO
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key8778341
MDR Text Key150678133
Report Number1213643-2019-05965
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/28/2020
Device Catalogue Number5955600
Device Lot NumberHUCU0523
Was Device Available for Evaluation? No
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age41 YR
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