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 2014-08-05 for 3612 LITE GLOVE 31140257 manufactured by Covidien.
[4957006]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a lite glove. The customer reports that during an orthopedic surgery, the lite glove became loose in two parts. The customer further reports that the lite glove was torn and it was noted at the end of the surgery. The patient was prescribed antibiotics as a result of this incident. This incident did not prolong the surgery.
Patient Sequence No: 1, Text Type: D, B5
[11934504]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2014-00042 |
| MDR Report Key | 3999026 |
| Report Source | 01,06,07 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-08-01 |
| Date Mfgr Received | 2014-08-01 |
| Date Added to Maude | 2014-08-20 |
| 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 | 2014-08-05 |
| Returned To Mfg | 2014-07-22 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 3283100664X |
| 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 CUI TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-05 |