MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-08-28 for COTTON TIPPED APPLICATOR, 6INCH, 2 PAC 8884541400 manufactured by Citmed Corp.
[3766269]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with the cotton tipped applicators. The customer stated that the cotton tips are not present on the sticks. The sticks are also breaking while using them, up towards the tip of the cotton part of the stick.
Patient Sequence No: 1, Text Type: D, B5
[11220083]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2013-00032 |
| MDR Report Key | 3391567 |
| Report Source | 04 |
| Date Received | 2013-08-28 |
| Date of Report | 2013-08-09 |
| Date Mfgr Received | 2013-08-09 |
| Date Added to Maude | 2013-11-29 |
| 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 | CITMED CORP |
| Manufacturer Street | 18601 SOUTH MAIN ST PO BOX 67 |
| 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 | COTTON TIPPED APPLICATOR, 6INCH, 2 PAC |
| Generic Name | COTTON TIP APPLICATOR |
| Product Code | KXG |
| Date Received | 2013-08-28 |
| Model Number | 8884541400 |
| Catalog Number | 8884541400 |
| Lot Number | 13001 |
| 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 CORP |
| Manufacturer Address | 18601 SOUTH MAIN ST CITRONELLE AL 36522 US 36522 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-28 |