MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-23 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[18363933]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a lite glove. The customer reports that the lite glove came off during surgery in the operating room. As a result, the entire wound was thoroughly irrigated with normal saline. The field had to be re-sterilized. The surgical team re-gowned, re-gloved and re-draped. The pt was not prescribed any medications as a result of this incident. An estimated 15 minutes were added to the procedure time.
Patient Sequence No: 1, Text Type: D, B5
[18586902]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2013-00026 |
| MDR Report Key | 3316235 |
| Report Source | 06 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-08-15 |
| Report Date | 2013-08-15 |
| Date Reported to Mfgr | 2013-08-15 |
| Date Mfgr Received | 2013-08-15 |
| Date Added to Maude | 2013-09-05 |
| 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 | 3 |
| Manufacturer Contact | ASHLEY HARVEY |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084521480 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD INSURGENTES A LA P, LA MESA |
| 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 | FQP |
| Date Received | 2013-08-23 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 123250003X |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-23 |