MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-26 for SILK SUTURE UNKNOWN - SILK manufactured by Covidien.
[19299445]
Procedure: unknown; according to the reporter: the first procedure was performed in late (b)(6). The additional procedure of open surgery was required on (b)(6) because the reaction against the foreign material was observed. Then the customer confirmed the conglutination and twitch in the seromuscular part that had been sutured by use of the concerning product and others. The patient current status: unknown. Operating time not extended. Tissue damage: yes. Nothing fell into the cavity. No bleeding. The customer could not identify exactly the product id that could cause the adverse event but reported it might be gsj37m or gsj63m.
Patient Sequence No: 1, Text Type: D, B5
[19372327]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00297 |
| MDR Report Key | 4044905 |
| Report Source | 06 |
| Date Received | 2014-08-26 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-08-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY - QA |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925154 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO KM17 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | KM17 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILK SUTURE |
| Generic Name | SILK SUTURE |
| Product Code | GAO |
| Date Received | 2014-08-26 |
| Catalog Number | UNKNOWN - SILK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO DO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-26 |