MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for 3611 LITE GLOVE 31140208 manufactured by Covidien.
[52386449]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[52386450]
It was reported to covidien on 07/21/2016 that a customer had an issue with a lite glove. The customer reports that the device torn off during application.
Patient Sequence No: 1, Text Type: D, B5
[60676897]
Submit date: 11/10/2016. The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. A decontaminated sample without original package or lot number was received and the reported issue was confirmed; the sample presents tear along the handle. A corrective and preventative action (capa) has been opened to determine the root cause of this reported event. When root cause(s) is determined the appropriate actions will be taken to address the reported condition. If additional information is received this complaint will be reopened. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2016-00343 |
| MDR Report Key | 5842731 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-21 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2016-08-03 |
| 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 ALMEDIA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| 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 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3611 LITE GLOVE |
| Generic Name | LITE GLOVE |
| Product Code | LYZ |
| Date Received | 2016-08-03 |
| Model Number | 31140208 |
| Catalog Number | 31140208 |
| Lot Number | 5249100264X |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-08-03 |