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 |