MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-03 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[64025147]
Submit date: 01/03/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[64025148]
It was reported to covidien on 12/14/2016 that a customer had an issue with a lite glove. The customer states that the lite glove was pulled over the handle per instructions for use. At the end of the lumbar vertebra surgery, it was found that the glove had tears. There was no additional medication given to the patient since they were provided antibiotics for the surgery. The patient is well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2017-00001 |
| MDR Report Key | 6219173 |
| Date Received | 2017-01-03 |
| Date of Report | 2016-12-14 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2017-01-03 |
| 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 |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3612 LITE GLOVE |
| Generic Name | LITE GLOVE |
| Product Code | FMC |
| Date Received | 2017-01-03 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 6158100364 |
| Operator | HEALTH PROFESSIONAL |
| 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 MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-03 |