MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-12 for ALTIS KIT 5196502400 519650 manufactured by Coloplast A/s.
[182781991]
The lot number was reviewed for complaint trend, nonconforming report and capa review. No trends were noted. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[182781992]
According to the available information, six days after the altis was implanted, the patient had a violent sneeze, heard a pop and became incontinent again. When the physician went in to fix the issue, the mesh had pulled away from blue suture on static side and suture was hanging from the anchor and could be felt by physician. A supris mesh ws implanted. It was reported there were no additional consequences. Per the report, the dissection was at least 1. 5cm wide and dissected back to the sulcus to allow for adequate space for proper sling placement. The final placement of the altis sling was at 10 and 2 o'clock position. The introducer was parallel to the descending pubic ramus when passing both anchors. There was nothing unique about the patient's anatomy. When the dynamic suture was pulled across the patient's midline, proper tensioning was achieved to support the urethra.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00123 |
| MDR Report Key | 9700772 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-09-23 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-12 |
| 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 | STEPHANIE PERRYMAN |
| 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 KIT |
| Generic Name | SURGICAL MESH |
| Product Code | PAH |
| Date Received | 2020-02-12 |
| Model Number | 5196502400 |
| Catalog Number | 519650 |
| Lot Number | 6625371 |
| 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. Other | 2020-02-12 |