N
Patient 1
SUBMIT DATE: 04/12/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5570745
- MDR report key
- 5570745
- Report number
- 1018120-2016-00058
- Event key
- 0
- Event type
- 3
- Date received
- 2016-04-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- THOM MCNAMARA
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-12 | 0 | 1. R |
Event Narratives#
D
Patient 1
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.
N
Patient 1
SUBMIT DATE: 04/20/2016. A CORRECTION HAS BEEN MADE TO UPDATE THE PLANT LOCATION THAT WAS REPORTED FROM (B)(4).
N
Patient 1
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.