MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-05-15 for BALLOON SLG 16FR X 2.0CM 716200 manufactured by Covidien.
[3564251]
It was reported to covidien on (b)(4) 2013 that a customer had an issue with a balloon slg. The customer stated they noticed in the morning that the device came out and was still attached to the machine. The customer reports the patient missed half the feed as a result, and his medications were within the feed. The medications were: florinef, nephro vite and enalapril. The customer took her son to the doctor in the morning, and lab work was done and were within range. The doctor also advised the patient's mother to discontinue the use of the florinef. The customer further stated that they had to repeat the lab work two times in one week to make sure her son was okay.
Patient Sequence No: 1, Text Type: D, B5
[10744448]
Submit date: (b)(4) 2013. An investigation is currently underway, upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2013-00014 |
| MDR Report Key | 3127017 |
| Report Source | 04 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-04-24 |
| Date Mfgr Received | 2013-04-24 |
| Date Added to Maude | 2013-05-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON SELBY |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON SLG 16FR X 2.0CM |
| Generic Name | BUTTON |
| Product Code | GDI |
| Date Received | 2013-05-15 |
| Model Number | 716200 |
| Catalog Number | 716200 |
| Lot Number | A1022411 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-15 |