MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-12-05 for SURGIPRO 0 30 BLUE GS-21 103P CP424 manufactured by Covidien.
[5194000]
The doctor was performing an epigastric ventral hernia repair to a (b)(6) year old patient. After sewing the patient, the suture broke causing the hernia to break again and the patient had cardiac arrest. He recovered from the heart failure and was operated on again. The patient is recovering with a good evolution.
Patient Sequence No: 1, Text Type: D, B5
[12450911]
Initial report sent to fda on 012/5/2014.
Patient Sequence No: 1, Text Type: N, H10
[13110844]
(b)(4). Follow up 01 sent to fda on 03/24/2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00440 |
| MDR Report Key | 4299997 |
| Report Source | 01,05 |
| Date Received | 2014-12-05 |
| Date of Report | 2014-11-13 |
| Date of Event | 2014-10-25 |
| Date Mfgr Received | 2014-11-13 |
| Date Added to Maude | 2014-12-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06743 |
| Manufacturer Country | US |
| Manufacturer Postal | 06743 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIPRO 0 30 BLUE GS-21 103P |
| Generic Name | SURGIPRO |
| Product Code | GAS |
| Date Received | 2014-12-05 |
| Returned To Mfg | 2015-02-03 |
| Model Number | CP424 |
| Catalog Number | CP424 |
| Lot Number | D3J1165X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-05 |