MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-25 for 90017966 COTTON TIPPED APPLICATOR, 6 INCH, BULK 8884540500 manufactured by Cm Americas.
[54043483]
An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[54043484]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a cotton tip applicator. The customer states that the tips are falling apart. The cotton comes off the stick.
Patient Sequence No: 1, Text Type: D, B5
[56261830]
Submit date: 09/28/2016. There were no samples received with this complaint therefore an examination of the reported condition could not be made. A review of the device history record was not performed during this investigation as the lot number was not received with the complaint. All device history records are reviewed and approved by quality prior to release of product. Because there was no lot number, a date of manufacture could not be determined. A possible root cause is that an insufficient amount of glue was dispensed onto the stick to hold the cotton. Since this complaint will be considered as unconfirmed, no corrective or preventive actions will be taken at this time. If additional information or samples are received, the investigation will resume as needed. This complaint will be used for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00645 |
| MDR Report Key | 5903797 |
| Date Received | 2016-08-25 |
| Date of Report | 2016-07-28 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-08-25 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90017966 COTTON TIPPED APPLICATOR, 6 INCH, BULK |
| Generic Name | COTTON TIPPED APPLICATOR |
| Product Code | KXF |
| Date Received | 2016-08-25 |
| Model Number | 8884540500 |
| Catalog Number | 8884540500 |
| Lot Number | ASKU |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CM AMERICAS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-25 |