MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[62697218]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[62697219]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports the light gloves are tearing up the middle upon application to the devon light handles. The material seems to differ in thickness and density depending on what section. The section that slips onto the handles is where the damage is occurring and appears to be more transparent/thinner than the cuff and tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2016-00817 |
| MDR Report Key | 6174784 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2016-12-05 |
| Date Added to Maude | 2016-12-15 |
| 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 | 2016-12-15 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 6158100364 |
| Device Availability | Y |
| 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 | 2016-12-15 |