MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-13 for ALTIS SINGLE INCISION SLING SYSTEM 5196501022 519650 manufactured by Coloplast A/s.
[183366952]
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
[183366953]
According to the available information,patient had an altis procedure on (b)(6) 2016. Since (b)(6) 2019, recurrent urinary infection and urethral pain after micturition. On (b)(6) 2019 patient diagnosis of urethral mesh erosion. Underwent revision of altis sling (partial removal under general anesthesia) on (b)(6) 2019. On (b)(6) 2020, patient had neither pain nor urinary infection, resolved was noted for status of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00240 |
| MDR Report Key | 9832365 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH O'GARA |
| 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 | 2020-03-13 |
| Model Number | 5196501022 |
| Catalog Number | 519650 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-13 |