MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-05-16 for DIGITEX SUTURE DELIVERY DEVICE 5202501022 manufactured by Coloplast A/s.
[108438001]
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
[108438002]
According to the available information, when using the trigger, the noise was louder and the hook of the clamp broke in two parts. The needle and the wire remained attached to the end of the clamp. Longer duration of the intervention with the use of a new digitex. Increased bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2018-00376 |
| MDR Report Key | 7519575 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-16 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-16 |
| 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 RIVIER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6124345685 |
| 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 | 2018-05-16 |
| Returned To Mfg | 2018-05-31 |
| Model Number | 5202501022 |
| Catalog Number | 5202501022 |
| Lot Number | 5666906 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-16 |