MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for ALTIS SLING 519650 manufactured by Coloplast A/s.
[177977158]
Patient had a combination surgery robotic xi hysterectomy and robotic xi tape sling. The sling was a coloplast altis sling. When the physician used the grasping teeth that hold the sling in place. The grasping teeth broke off in the patient and could not be found. A second sling was used. When the physician pulled on the mesh the suture piece disconnected from the mesh and could not be used. It was removed without difficulty. A third sling was used and it worked correctly. The grasping teeth that fell off are meant to be in the patient and the physician and coloplast representative stated that there would be no harm to the patient. Manufacturer response for altis sling, altis sling (per site reporter). Sales representative was in the room and stated that there would be no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9676548 |
| MDR Report Key | 9676548 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-11-01 |
| Report Date | 2020-01-02 |
| Date Reported to FDA | 2020-01-02 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTIS SLING |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE FEMALE |
| Product Code | PAG |
| Date Received | 2020-02-06 |
| Model Number | 519650 |
| Lot Number | 6684422 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | 1601 WEST RIVER ROAD MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |