MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-05-22 for DIGITEX SUTURE DELIVERY DEVICE 5202502400 manufactured by Coloplast A/s.
[108976256]
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[108976257]
As reported to coloplast though not verified, patient's legal representative stated, the patient had issues after the procedure due to pain. The patient stated at a later time that she was improving. Additional information received indicated the patient's legal representative stated at least one of the stitches made by the physician, under the guidance of another physician, via the digitex device, was made through the pudendal nerve, the pudendal nerve bundle and/or one of it's branches, causing the patient to suffer pudendal neuralgia, along with other associated serve nerve pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2018-00392 |
| MDR Report Key | 7535190 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-18 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-05-22 |
| 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 | SARAH O'GARA |
| Manufacturer Street | 1601 WEST RIVIER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123578517 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVIER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGITEX SUTURE DELIVERY DEVICE |
| Generic Name | SUTURE DELIVERY SYSTEM |
| Product Code | PWI |
| Date Received | 2018-05-22 |
| Model Number | 5202502400 |
| Catalog Number | 5202502400 |
| Operator | PHYSICIAN |
| 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 | 2018-05-22 |