MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-06 for BARD AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM 486100 manufactured by C.r. Bard, Inc. (covington) -1018233.
[187854397]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[187854398]
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, disability and impairment. Per additional information received, the patient has experienced complications from mesh requiring excision of mesh, anterior repair, laparoscopic hysterectomy, bilateral salpingo-oophorectomy, laparoscopic colpopexy (suture only) on ((b)(6) 2014), pelvic pain, dyspareunia, pain with bending and squatting, cystocele, hernias, pelvic tumors or fibroids, rectocele, recurrent vaginal pain, uterine prolapse and vaginal vault prolapse. The patient has experienced mesh erosion, uterine prolapse, pelvic pain, dyspareunia, dense scar plating around the mesh/dense band of scar tissue along the anterior vaginal wall just inside the introitus at the level of the mid distal urethra, severe abdominal pain, headaches, constant pelvic discomfort, contracted mesh, chronic pain, mesh embedded deeply in tissue (foreign body in patient), and required additional surgical and non surgical interventions. The patient has experienced mesh complications, prolapse, pelvic discomfort, dyspareunia, vaginal pulling sensation (foreign body sensation), difficulty emptying bladder, elevated blood pressure, tenderness, foreign body in patient, pelvic pain, erosion, scarring (scar tissue), defect, blood loss, adenomyosis, leiomyomas, inflammation, endometriosis, nodules, ovarian atrophy, fibrosis, hematoma, spotting, pink discharge, vaginal pain, anemia, abdominal pain, headache, pain, vaginal bleeding, nonsurgical and additional surgical interventions. The patient has experienced postoperative urinary retention, vulvodynia, left lower quadrant pain, bulge discomfort with increasing heaviness, back pain, stage 2 uterine prolapse with the cervix protruding out about 1 cm past the introitus, banding in the anterior graft and pain at the site where it inserts and the right levator ani muscles, banding on the left side, scarred and shortened anterior vaginal wall,? Pulling? Sensation to the urethral area, possible urinary tract infection, back spasm, difficult time emptying her bladder on occasion, palpable mesh along the anterior vaginal wall, mesh tight and very tender to examination, dense scar plating around the mesh, urine frequency, urgency, flank pain, constipation, vaginal atrophy, persistent mesh as well as damage to the adjacent tissues, mesh folded and contracted on itself bilaterally and findings consistent with nerve entrapment, dense scarification, and impingement upon adjacent tissues, bladder pain, and chronic mesh pain, anxiety arising from the complications of mesh and loss of consortium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01607 |
| MDR Report Key | 9800143 |
| Report Source | OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2009-06-16 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGELA ROBINSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM |
| Generic Name | BARD AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM |
| Product Code | OTP |
| Date Received | 2020-03-06 |
| Catalog Number | 486100 |
| Lot Number | HUTF0676R |
| Device Expiration Date | 2011-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 19 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |