MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[115900949]
(b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: european journal of obstetrics & gynecology and reproductive biology. 2008; 139: 245 251. Doi: 10. 1016/j. Ejogrb. 2008. 01. 013 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115900990]
Journal article title : vaginal reconstructive surgery for severe pelvic organ prolapses: a? Uterine-sparing? Technique using polypropylene prostheses. The ulmsten? S?? Integral theory?? For pelvic floor dysfunctions is based on the need to reinforce fascias and ligaments with prostheses to obtain a reconstitution of the pelvic floor? S anatomy. In september 2004, the authors developed a?? Uterine-sparing?? Surgical technique to correct such pathologies. The primary outcome of the study was to evaluate the technique? S efficacy and the secondary outcome was the resolution of stress urinary incontinence, postoperative pain, safety and complications. This prospective study included 80 patients (age range: 38 to 74 years old) affected by stage 3 and 4 uterine-vaginal prolapse who wished to conserve their uterus. The authors performed an anterior-central vaginal reconstruction in 35 patients (group 1), central-posterior in 25 patients (group 2), and total reconstruction in 20 patients (group 3). During the surgical procedure in all groups, the gynecare gynemesh-soft ps mesh (ethicon) were used to reconstruct the pubo-cervix and the recto-vaginal fascia. They were prepared cutting four?? Arms?? From the initial mesh and were subsequently washed in a cephalosporin solution prior to insertion. The authors used 1 mesh to repair the anterior-central compartment, 1 for the central-posterior compartment, and 2 for the total prolapse repair (both compartments). For group 1, the authors inserted and fixed the prosthesis to the sacrospinous ligament (ssl) with polyester 1-0 (ethicon) using an endostitch device. This represents the first level of suspension for the vaginal apex. For group 3, both techniques from groups 1 and 2 were combined and applied in this study group. In group 1, reported complications included vaginal erosion (n-1) which required local excisions of the visible graft and suturing of the vagina. In group 3, reported complications included vaginal erosion (n-2) which required local excisions of the visible graft and suturing of the vagina and post-operative dyspareunia (n-1) which was successfully resolved with the prosthesis removal. It was reported that prostheses were intentionally created with 4 arms in order to fix them deep inside pelvic structures. These multiple lateral attachments could explain the absence of recurrences. This pilot study suggests that the technique can efficiently repair severe pelvic organ prolapses, restore a normal horizontal axis of the vagina, and a normal sexual life without removing the uterus, without recurrences and with a low rate of vaginal erosions
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-74865 |
| MDR Report Key | 7745712 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-07-18 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-02 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2018-08-02 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-02 |