MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-23 for CHROMIC GUT CG-905 manufactured by Davis & Geck Caribe Ltd.
[176046472]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176046473]
According to the reporter, during caesarian section procedure, while the surgeon performing anchor stitch on the left uterine site, the device needle broke and the needle tip fell into the patient cavity. To resolve the issue the surgeon performed an x-ray to locate the needle but it was not found and decided to left the needle tip inside the patient to avoid causing more trauma. The surgical time was extended for about 30 minutes, there were also tissue damage and the patient had blood loss for about 650cc due to the product problem. To complete the case the surgeon used another suturing device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2020-00139 |
| MDR Report Key | 9621228 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-08-10 |
| Date Added to Maude | 2020-01-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 0101 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMIC GUT |
| Generic Name | SUTURE, ABSORBABLE, NATURAL |
| Product Code | GAL |
| Date Received | 2020-01-23 |
| Model Number | CG-905 |
| Catalog Number | CG-905 |
| Lot Number | D9H1109ZY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-23 |