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 2016-09-27 for 3611 LITE GLOVE 31140208 manufactured by Covidien.
[55715085]
Submit date: 9/27/2016. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[55715086]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports: lites gloves breaks during introduction onto the handle of the operating lamp resulting in non sterilized of the surgeon if the operating lamp is taken in hand during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2016-00467 |
| MDR Report Key | 5979843 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-27 |
| Date of Report | 2016-09-23 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-09-27 |
| 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 | 2016-09-27 |
| Model Number | 31140208 |
| Catalog Number | 31140208 |
| Lot Number | 6139100164 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-27 |