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 ALTIS SINGLE INCISION SLING SYSTEM 5196502400 519650 manufactured by Coloplast A/s.
[188368865]
(b)(4). The lot number was reviewed for complaint trend, nonconforming report and capa. Devices met specification prior to release and no trends were noted. Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[188368866]
As reported to coloplast though not verified, patient's legal representative stated on or about (b)(6) 2014, plaintiff underwent a surgical procedure during which her physicians implanted transvaginal mesh with the altis device. Plaintiff subsequently treated with her physicians for complications including, but not limited to: severe pain with daily activities and intercourse. On or about (b)(6) 2017, plaintiff underwent a surgical procedure during which her physicians excised and removed a portion of the altis mesh due to mesh exposure. Plaintiff suffered and continues to suffer multiple severe and painful personal injuries, included but not limited to, vaginal prolapse, urinary incontinence, physical deformity, the loss of the ability to perform sexually. Plaintiff suffered serious and grievous personal injuries, including erosion of the vaginal wall and other tissues, infection, permanent and substantial physical deformity, and the loss of the ability to perform sexually, as well as other grievous personal injuries, including but not limited to, physical pain and mental anguish and permanently diminished enjoyment of life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00206 |
| MDR Report Key | 9801886 |
| Report Source | OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2020-02-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN PRIOLEAU |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTIS SINGLE INCISION SLING SYSTEM |
| Generic Name | SURGICAL MESH |
| Product Code | PAH |
| Date Received | 2020-03-06 |
| Model Number | 5196502400 |
| Catalog Number | 519650 |
| Lot Number | 4060195 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2020-03-06 |