MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-10 for CONTIGEN? BARD? COLLAGEN IMPLANT 651005 manufactured by C.r. Bard, Inc. (covington) -1018233.
[129877122]
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: "urological applications. Adverse events associated with treatment may include but are not limited to: worsened incontinence; urinary retention; urinary tract infection; and/or localized responses (including swelling, erythema, induration, infection, necrosis, abscess formation, and/or hypersensitivity response). In the clinical evaluation of contigen implant, two of the 78 treatment-related events (one event of urinary retention and one para-urethral abscess) were the result of local hypersensitivity reactions to contigen implant. In each case, the problem resolved within one month without loss of effectiveness. Urinary tract infection occurred in approximately 20% of treated patients. Urinary tract infection occurred most frequently in female patients and generally was not related to treatment. Generally, those infections resolved with appropriate antibiotic therapy and without sequelae. Urinary retention thought to result from overcorrection with contigen implant occurred in approximately 9% of patients and generally was managed with clean intermittent catheterization. Urethritis and bladder outlet obstruction occurred in approximately 2% of treated patients, and less than 2% of male patients experienced balanitis. In the clinical evaluation, approximately 7% of patients treated experienced transient worsened incontinence (1-6 months), and approximately 3% of patients treated experienced worsened incontinence which did not improve during study participation. Slight discomfort and mild bleeding will probably occur at the injection site immediately following the injection procedure. In the clinical evaluation, approximately 2% of treated patients reported pain at the injection site or injection site injury. Transient gross hematuria may occur immediately following the injection procedure. In the clinical evaluation of contigen implant, postprocedure hematuria occurred in approximately 2% of treated patients. The patient should be told to report increasing discomfort or swelling to the physician. "(b)(4) sample not returned.
Patient Sequence No: 1, Text Type: N, H10
[129877123]
It was reported in the patients medical records that as a result of having the product implanted, the patient has experienced pain, enterocele, rectocele (prolapse), nausea, atrophy, adhesions, cyst, pelvic prolapse, vomiting, scarring, scar tissue, blood loss, embedded mesh, nonsurgical and additional surgical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-05924 |
| MDR Report Key | 8148047 |
| Report Source | OTHER |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2010-04-06 |
| Date Added to Maude | 2018-12-10 |
| 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 | CONTIGEN? BARD? COLLAGEN IMPLANT |
| Generic Name | CONTIGEN? BARD? COLLAGEN IMPLANT LNM |
| Product Code | LNM |
| Date Received | 2018-12-10 |
| Model Number | NA |
| Catalog Number | 651005 |
| Lot Number | BMUD0006 |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 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 | 2018-12-10 |