MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-02 for UNKNOWN SUTURE PRODUCT UNKNOWN - SUTUR manufactured by Covidien.
[32498755]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32498756]
According to the reporter: during a c-section, the needle tip broke off in the patient. An x-ray was performed and the x-ray came back clear. This added an additional 30 to 40 minutes to the surgery. Another suture was used to finish the case. Currently the patient is doing well. Additional information has been requested but not yet received
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2015-00761 |
| MDR Report Key | 5260876 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-02 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2015-11-19 |
| Date Added to Maude | 2015-12-02 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN SUTURE PRODUCT |
| Generic Name | UNKNOWN SUTURE |
| Product Code | GAO |
| Date Received | 2015-12-02 |
| Model Number | UNKNOWN - SUTUR |
| Catalog Number | UNKNOWN - SUTUR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2015-12-02 |