MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-19 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[4849767]
It was reported to covidien on (b)(4) 2014 that a customer had an issue with a lite glove. The customer reports that the lite glove tore during use. It was noticed toward the end of the case and the pt was prescribed antibiotics as a precautionary measure.
Patient Sequence No: 1, Text Type: D, B5
[11992626]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9612030-2014-00047 |
MDR Report Key | 4038004 |
Report Source | 06 |
Date Received | 2014-08-19 |
Date of Report | 2014-08-11 |
Date Mfgr Received | 2014-08-11 |
Date Added to Maude | 2014-09-02 |
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 | JANICE NEVIUS |
Manufacturer Street | 15 HAMPSHIRE ST. |
Manufacturer City | MANSFIELD MA 02048 |
Manufacturer Country | US |
Manufacturer Postal | 02048 |
Manufacturer Phone | 5082616283 |
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 | 3612 LITE GLOVE |
Generic Name | LITE GLOVE |
Product Code | FQP |
Date Received | 2014-08-19 |
Model Number | 31140257 |
Catalog Number | 31140257 |
Lot Number | 4147103364X |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COVIDIEN |
Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2014-08-19 |