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 AVAULTA SOLO? SYNTHETIC SUPPORT SYSTEM - ANTERIOR 486100 manufactured by C.r. Bard, Inc. (covington) -1018233.
[187850688]
The sample was not returned. The finished product met all specifications prior to being released for general distribution. The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials. The instructions for use states in the adverse events:? Potential adverse reactions are those typically associated with surgically implantable materials, including hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse. Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187850689]
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment. Per additional information received, the patient has experienced vaginal mesh erosion, exposure, bacterial vaginosis, bleeding, vaginal discharge, bulging sensation, occasional urgency, rare urinary urge incontinence, stage iii + cervical elongation. She has required nonsurgical interventions and one surgical intervention to remove vaginal sling or mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01603 |
| MDR Report Key | 9799513 |
| Report Source | OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2007-12-04 |
| 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 | AVAULTA SOLO? SYNTHETIC SUPPORT SYSTEM - ANTERIOR |
| Generic Name | AVAULTA SOLO? SYNTHETIC SUPPORT SYSTEM - ANTERIOR |
| Product Code | OTP |
| Date Received | 2020-03-06 |
| Catalog Number | 486100 |
| Lot Number | CVRK0016 |
| Device Expiration Date | 2008-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 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 |