MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-04-21 for 3613 LITE GLOVE 31140216 manufactured by Covidien.
[5736107]
Customer states they opened the package and the light glove was sliced.
Patient Sequence No: 1, Text Type: D, B5
[13272911]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[25372836]
The device history record was reviewed and indicated that the product was released accomplishing all quality standards. A sample was received for evaluation. A visual inspection was performed and the reported issue was confirmed. The handle of the lite glove was ripped. The split in the lite glove handle is caused by a pleat generated during the thermoforming process due to geometry of the product/ mold design. This pleat creates weakness on the neck of the lite glove. A formal corrective and preventative action was opened for this reported issue. The manufacturing personnel were trained and made aware of this reported issue. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2015-00046 |
| MDR Report Key | 4715036 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-16 |
| Date of Event | 2015-04-10 |
| Date Mfgr Received | 2015-08-04 |
| Date Added to Maude | 2015-05-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| 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 | 3613 LITE GLOVE |
| Generic Name | LITE GLOVE |
| Product Code | FQP |
| Date Received | 2015-04-21 |
| Model Number | 31140216 |
| Catalog Number | 31140216 |
| Lot Number | 5002108064X |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-04-21 |