MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-06 for 90017966 COTTON TIPPED APPLICATOR, 6 8884541400 manufactured by Citmed Corporation.
[4205208]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a cotton tipped applicator. The customer reports that the stick broke just below the cotton tip while cleaning the stoma and the trachea. The customer further reports that the broken pieces fell into her son's airway and occluded it. Nine one one was called into her son was taken by ambulance to the hospital er. The broken piece was removed at the hospital and her son is in good status currently.
Patient Sequence No: 1, Text Type: D, B5
[11629066]
An investigation is currently underway. Upon completion, the results will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2014-00012 |
| MDR Report Key | 3644479 |
| Report Source | 04 |
| Date Received | 2014-02-06 |
| Date of Report | 2014-01-31 |
| Date of Event | 2013-12-13 |
| Date Mfgr Received | 2014-01-31 |
| Date Added to Maude | 2014-04-03 |
| 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 | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | CITMED CORPORATION |
| Manufacturer Street | 18601 SOUTH MAIN STREET |
| Manufacturer City | CITRONELLE AL 36522 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36522 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90017966 COTTON TIPPED APPLICATOR, 6 |
| Generic Name | COTTON TIP APPLICATOR |
| Product Code | KXG |
| Date Received | 2014-02-06 |
| Model Number | 8884541400 |
| Catalog Number | 8884541400 |
| Lot Number | 13025 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CITMED CORPORATION |
| Manufacturer Address | 18601 SOUTH MAIN STREET CITRONELLE AL 36522 US 36522 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-06 |