MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-12-18 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[4202671]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a lite glove. The customer reports that the scrub nurse noticed the lite glove was split at the end of thjr. As they were unsure of when the split happened, they gave the patient an additional dose of antibiotics. The customer reports that this happened with two lite gloves during the same procedure. The customer further reports that the patient did not develop any post-operative infection and there was no adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[11685393]
Submit date: 12/17/2013. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2013-00046 |
| MDR Report Key | 3636970 |
| Report Source | 01,06,07 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-22 |
| Date Mfgr Received | 2013-11-22 |
| Date Added to Maude | 2014-03-28 |
| 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 | 2013-12-18 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 31140208 |
| 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 | 2013-12-18 |