N
Patient 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5960254
- MDR report key
- 5960254
- Report number
- 9612030-2016-00445
- Event key
- 0
- Event type
- 3
- Date received
- 2016-09-19
- 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
- EDWARD ALMEIDA
- Address
- 15 HAMPSHIRE ST MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-19 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS: GLOVE TORE WHILE PULLING IT OVER THE HANDLE. PATIENT WAS NOT PRESENT
N
Patient 1
SUBMIT DATE: 11/17/2016. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED OR DATE OF MANUFACTURE IDENTIFIED AS THE LOT NUMBER PROVIDED WAS NOT VALID AND COULD NOT BE VERIFIED BY THE CUSTOMER. ALL DHR'S ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR DISTRIBUTION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A THOROUGH FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND ROOT CAUSE ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED EVENT. WHEN ROOT CAUSE(S) IS DETERMINED THE APPROPRIATE ACTIONS WILL BE TAKEN TO ADDRESS THE REPORTED CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.