MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-26 for 3611 LITE GLOVE 31140208 manufactured by Kenmex.
[55584522]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[55584523]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer states that the lite gloves are too tight and split when trying to place on the lamp handle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2016-00459 |
| MDR Report Key | 5976461 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-26 |
| Date of Report | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-09-26 |
| 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 | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| 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 | LYU |
| Date Received | 2016-09-26 |
| Model Number | 31140208 |
| Catalog Number | 31140208 |
| Lot Number | 6162100464 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENMEX |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-26 |