MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2016-04-12 for 90017966 COTTON TIPPED APPLICATOR, 6 INCH, TWO PAC 8884541400 manufactured by Covidien.
[42438602]
Submit date: 04/12/2016. An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[42438603]
It was reported to covidien on 2016 that the customer had an issue with a cotton tipped applicator. Reported issue: the customers wife was draining and cleaning his wound when the cotton part came off of the applicator inside of his wound. He needed to have outpatient surgery and the doctor had to cut open a hole 3" to get it out.
Patient Sequence No: 1, Text Type: D, B5
[43531160]
Submit date: 04/20/2016. A correction has been made to update the plant location that was reported from (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45760587]
An investigation of the reported condition was performed on may 20, 2016 by (b)(4). A complaint of ¿? Reported issue: the customer¿? S wife was draining and cleaning his wound when the cotton part came off of the applicator inside of his wound. He needed to have outpatient surgery and the doctor had to cut open a hole 3" to get it out" was received for the 90017966 cotton tipped applicator, 6 inch, two pac. There were no samples received with this complaint therefore an examination of the defect could not be made. The defect could not be confirmed. A dhr review was completed for lot number 15014. There were no manufacturing issues related to the complaint issued for this lot. This complaint will be considered unconfirmed. The root cause of the reported issue could not be identified with no sample and limited information received. As the complaint is unconfirmed and a root cause could not be identified, no corrective action is planned at this time. A trend analysis was performed for complaint code cotton tip falling off applicator during use, involving product code 8884541400 since the complaint date (april 12, 2015 to may 20, 2016). One additional complaint has been received with a similar defect during 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 | 1018120-2016-00058 |
| MDR Report Key | 5570745 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2016-04-12 |
| Date of Report | 2016-04-12 |
| Date Mfgr Received | 2016-05-23 |
| Date Added to Maude | 2016-04-12 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| 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, TWO PAC |
| Generic Name | COTTON TIPPED APPLICATOR |
| Product Code | KXF |
| Date Received | 2016-04-12 |
| Model Number | 8884541400 |
| Catalog Number | 8884541400 |
| Lot Number | 15014 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD AUGUSTA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-12 |