MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for ALTIS SINGLE INCISION SLING SYSTEM 5196502400 519650 manufactured by Coloplast A/s.
[186564614]
The lot number was reviewed for complaint trend, nonconforming report and capa. Devices met specification prior to release and no trends were noted. The device has been received at coloplast; however the evaluation is not yet complete. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Once our evaluation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186564617]
According to the available information, infection was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00258 |
| MDR Report Key | 9884504 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | 2020-03-26 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 5196502400 |
| Catalog Number | 519650 |
| Lot Number | 6711964 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2020-03-26 |