MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for DEVON LITE GLOVE LIGHT HANDLE SYSTEMS 31140257 manufactured by Covidien.
[23255307]
Patient Sequence No: 1, Text Type: N, H10
[23255408]
Current packaging curls the side of the light handles. Light handles do not flatten out while in use. This results in an incomplete covering of the non sterile handle which could cause contamination of the surgical team during the surgical case. The packaging problem is present in multiple lots with multiple devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5010309 |
| MDR Report Key | 5010309 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-08-03 |
| Report Date | 2015-08-03 |
| Date Reported to FDA | 2015-08-03 |
| Date Reported to Mfgr | 2015-08-03 |
| Date Added to Maude | 2015-08-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVON LITE GLOVE LIGHT HANDLE SYSTEMS |
| Generic Name | COVER, BARRIER, PROTECTIVE |
| Product Code | MMP |
| Date Received | 2015-08-18 |
| Catalog Number | 31140257 |
| Lot Number | 5153101664X |
| Device Expiration Date | 2018-06-20 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-18 |