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Catalog Number UNKAA069
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Tachycardia (2095); Disability (2371)
Event Date 04/04/2019
Event Type  Injury  
Manufacturer Narrative
As reported, it is alleged that post-implant of the bard soft mesh, the patient experienced disability, pain, allergic reaction, inflammation and surgical intervention for mesh removal. Based on the information provided to date, no conclusion can be made as to the degree to which the bard soft mesh, may be causing or contributing the patient¿s reported symptoms. The adverse reaction section of the instructions-for-use, supplied with the device, identifies inflammation and pain as possible complications. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Should additional information be provided, a supplemental mdr will be submitted. Not returned.
Event Description
The following was reported via maude event report (mw5096812): allergic mesh reaction destroying my qol. Two devices; coloplast altis urethra sling and bard soft mesh for sacrocolpopexy. Coloplast altis sling at one week post op initiated repeated uti, pain and gait disturbance, where none existed before. Removal of mesh required travel to another state at one month post op for surgery and stopped uti but some urine retention and discomfort remain. Still testing for damage and possible pudendal nerve entrapment. Successful removal of the anchors required travel for a second removal surgery at 13 months post op at a specialist in (b)(6) clinic in (b)(6) from another state. Although both anchors were found and removed, the anchors are not always found and few surgeons will attempt it. This surgery requires thigh dissection. By the way, my surgeon did not discuss the sling surgery with me. He knew i had no urinary incontinence. I did not know i was scheduled for urinary sling surgery. Previously he cancelled my surgery because i had questions, so i couldn't ask about the surgery unless i took the risk of having it cancel again. The sacrocolpopexy mesh has created extremely disabling pain, disability and appears to have created new inflammation or increased inflammation body wide. The pain centers at the sacrum where the mesh is attached to a ligament to secure the vaginal vault from descending. The pain radiates along the pelvic bones and to the attached muscles. Everything inside and outside of my pelvis hurts including complications with my otherwise very healthy intestines. I was diagnosed with sibo recently, walking is difficult, fatigue and pain and recovery from activity has me sitting in a recliner on a heating massage pad 10- 15 hours a day. I have my own tens unit to help with the pain. I was very active before the mesh was installed in my pelvis. Mesh has increased inflammation throughout my body which is likely classified as autoimmune disease and different than simply local inflammation at the location of the mesh. I have a chronic blood cancer called polycythemia vera, a myeloproliferative neoplasm. It is characterized by some inflammation. The mesh has increased the symptoms beyond a manageable amount. Increased or different medications and even surgery are being considered to relieve symptoms. I am holding off significant changes until the mesh is hopefully removed. Other people have seen auto immune type of mesh reactions stop if mesh is removed. I had minor svt but now with mesh i have often increased heart rate and pounding heart rate. I am short of breath. I am waiting to schedule an appointment to have the mesh removed by leading expert dr (b)(6) in (b)(6). Many women have repeated unsuccessful surgeries. It will mean another out of state travel. The fifth and hotel stay for me and my husband during the risk of covid. I may never recover completely from these mesh complications and it is possible i could get worse. Mris, x-ray, us tests to look for pain causes found nothing. Now scheduled to look for inflammation markers for autoimmune. Fda safety report id#(b)(4).
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Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
MDR Report Key10790541
MDR Text Key214753168
Report Number1213643-2020-20034
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA069
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/05/2020 Patient Sequence Number: 1