MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-05 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[52422432]
Submit date: 08/05/2016. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[52422433]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports the light glove split when placed on the operating room light. The customer further stated that the lite glove is a little tight when placing on the handle, they have to continually (shove) it on the handle and is a little more challenging than before. The split/tear was found mostly when placing on the handle during setup. Once the split was noticed they would remove the top glove if they double glove, and if they single glove, they change the glove. The customer states that the material is really thin. A skytron aurora adapter is being used with the lite glove.
Patient Sequence No: 1, Text Type: D, B5
[56217734]
Submit date: 09/29/2016.
Patient Sequence No: 1, Text Type: N, H10
[57599900]
Submit date: 09/29/2016. Originally reported as ns-3600-b lite glove 1000/case and should be 3612 lite glove. Model number: originally reported as unknown or and should be 31140257. Catalog number: originally reported as unknown or and should be 31140257. Lot number: originally left blank and per the product received from the customer, the lot number is 6147100264.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2016-00366 |
| MDR Report Key | 5850318 |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-22 |
| Date Mfgr Received | 2016-09-29 |
| Date Added to Maude | 2016-08-05 |
| 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 | 3 |
| Brand Name | 3612 LITE GLOVE |
| Generic Name | LITE GLOVE |
| Product Code | LYZ |
| Date Received | 2016-08-05 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 6147100264 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-08-05 |