MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for UNKNOWN LITE GLOVE UNK OR manufactured by Covidien.
[59035994]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[59035995]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports they are finding that the handle gloves arrive split when taken from the packaging. The crack is almost always in the skirt. It does sometimes protrude up into the first inch of the handle. They have not noticed splitting during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2016-00597 |
| MDR Report Key | 6072815 |
| Date Received | 2016-11-02 |
| Date of Report | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-11-02 |
| 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 | UNKNOWN LITE GLOVE |
| Generic Name | LITE GLOVE |
| Product Code | LYU |
| Date Received | 2016-11-02 |
| Model Number | UNK OR |
| Catalog Number | UNK OR |
| 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 | 2016-11-02 |