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 2016-10-17 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[57576351]
Submit date: 10/17/2016. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[57576352]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports it was noted that the light handle cover has inconsistent material throughout the product. It is thin and flimsy causing product to tear/split when used. There was a patient involved and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2016-00525 |
| MDR Report Key | 6033108 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-17 |
| Date of Report | 2017-11-16 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2016-09-26 |
| Date Added to Maude | 2016-10-17 |
| 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 | LYU |
| Date Received | 2016-10-17 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 6169100264 |
| 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 | 2016-10-17 |