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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER; MESH, SURGICAL, POLYMERIC
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TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number IVS-02M
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Bacterial Infection (1735); Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Thrombus (2101); Urinary Tract Infection (2120); Vomiting (2144); Ulcer (2274); Injury (2348); Hematuria (2558); Blood Loss (2597); No Code Available (3191); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/10/2009
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post-operatively, the patient experience bleeding and macroscopic hematuria/ bleeding.There was also a urinary tract infection related problem with the product.The patient performed an examination under anesthesia for resection of mesh and for removal of a vaginal polyp.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient and their attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal vault prolapse and stress incontinence.It was reported that after implant, the patient experienced macroscopic hematuria, vaginal bleeding, part of the mesh broke through tissue, vaginal polyp, urinary tract infection, tiredness, regular infections, mesh exposed, frayed mesh, blood clot, leucocytes, bacterial infection, vomiting, scar tissue, and dyspareunia.Treatment for these issues included mesh resection, vagifem low, and vaginal polyp removal under anesthesia.The issues were temporarily resolved but later reoccurred.
 
Event Description
The patient and their attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal vault prolapse and stress incontinence.It was reported that after implant, the patient experienced macroscopic hematuria, vaginal bleeding, part of the mesh broke through tissue, vaginal polyp, urinary tract infection, tiredness, regular infections, mesh exposed, frayed mesh, blood clot, leucocytes, bacterial infection, vomiting, scar tissue, and dyspareunia.Treatment for these issues included mesh resection and vaginal polyp removal under anesthesia.The issues were temporarily resolved but later reoccurred.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient and their attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal vault prolapse and stress incontinence.It was reported that after implant, the patient experienced macroscopic hematuria, vaginal bleeding, part of the mesh broke through tissue, vaginal polyp, urinary tract infection, tiredness, regular infections, mesh exposed, frayed mesh, blood clot, leucocytes, bacterial infection, vomiting, scar tissue, anal fissure, blood in urine, pain, and dyspareunia.Treatment for these issues included mesh resection, vagifem low, cystoscopy, and vaginal polyp removal under anesthesia.The issues were temporarily resolved but later reoccurred.
 
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Brand Name
MESH BALLYMONEY - IVS TUNNELLER
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYCO HEALTHCARE UK MANF. LTD
20 garryduff road             
ballymoney,at BT53 7AP 
GB  BT53 7AP 
MDR Report Key9807036
MDR Text Key182697287
Report Number9615742-2020-00583
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K073164
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2013
Device Model NumberIVS-02M
Device Catalogue NumberIVS-02M
Device Lot Number08D069
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SPMM-35(LOT#: A9F0981)
Patient Outcome(s) Required Intervention;
Patient Age44 YR
Patient Weight55
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