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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ONFLEX SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 ONFLEX SURGICAL MESH Back to Search Results
Catalog Number UNKAA107
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Nerve Damage (1979); Pain (1994)
Event Date 06/15/2019
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, no conclusion can be made. We are unable to contact the reporter for additional information. No lot number has been provided; therefore, a review of the manufacturing records is not possible. As reported, the patient experienced pain, and migration post implant of the onflex mesh. The adverse reactions section of the instructions for use, supplied with this device lists, pain and migration as possible complications. Note, the date of event and date of implant are considered to be a best estimate as (b)(6) 2019 based on the available information. Should additional information be provided, a supplemental mdr will be submitted. Not returned.
 
Event Description
As alleged, the patient was implanted with a bard/davol onflex mesh. It was reported that the surgery took place "two years ago". It is alleged that the patient has had pain since surgery and allegedly an mri shows the mesh has migrated and is damaging other areas of the body. As reported, "the mesh will probably be removed as it seems to be hurting his nerves and one testicle. " as reported, the patient's doctor has proposed to re-operate. It is reported that the patient wants to continue in the pain clinic at this time and does not want to undergo re-operation.
 
Event Description
As alleged, the patient was implanted with a bard/davol onflex mesh. It was reported that the surgery took place "two years ago". It is alleged that the patient has had pain since surgery and allegedly an mri shows the mesh has migrated and is damaging other areas of the body. As reported, "the mesh will probably be removed as it seems to be hurting his nerves and one testicle. " as reported, the patient's doctor has proposed to re-operate. It is reported that the patient wants to continue in the pain clinic at this time and does not want to undergo re-operation.
 
Manufacturer Narrative
Based on the information provided, no conclusion can be made. We are unable to contact the reporter for additional information. No lot number has been provided; therefore, a review of the manufacturing records is not possible. As reported, the patient experienced pain, and migration post implant of the onflex mesh. The adverse reactions section of the instructions for use, supplied with this device lists, pain and migration as possible complications. Note, the date of event and date of implant are considered to be a best estimate as (b)(6) 2019 based on the available information. Addendum: this is an addendum to the initial mdr submitted. This supplemental mdr is submitted to remove the udi number, which was entered inadvertently in the initial mdr. Should additional information be provided, a supplemental mdr will be submitted.
 
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Brand NameONFLEX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key12617287
MDR Text Key276154602
Report Number1213643-2021-20356
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K142711
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA107
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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