MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for 3611 LITE GLOVE 31140208 manufactured by Covidien.
[65972143]
Submit date: 01/25/2017. An investigation is currently underway. Upon completion, the results will be forwarded. Mansfield product monitoring has attempted to gather additional information. To date, no additional information has been received. If additional pertinent information becomes available, the report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[65972144]
It was reported to covidien on 12/27/2016 that an issue occurred with a lite glove. The customer reports that the device tore off during application.
Patient Sequence No: 1, Text Type: D, B5
[66060331]
Submit date: 01/25/2017.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9612030-2017-00036 |
MDR Report Key | 6275751 |
Date Received | 2017-01-25 |
Date of Report | 2017-11-17 |
Date of Event | 2016-11-10 |
Date Mfgr Received | 2017-01-25 |
Date Added to Maude | 2017-01-25 |
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 ST |
Manufacturer City | MANSFIELD MA 02048 |
Manufacturer Country | US |
Manufacturer Postal | 02048 |
Manufacturer Phone | 5084524151 |
Manufacturer G1 | COVIDIEN |
Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
Manufacturer City | TIJUANA |
Manufacturer Country | MX |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 3611 LITE GLOVE |
Generic Name | LITE GLOVE |
Product Code | FMC |
Date Received | 2017-01-25 |
Model Number | 31140208 |
Catalog Number | 31140208 |
Lot Number | 6162100264 |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COVIDIEN |
Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-01-25 |