MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for NS-3600-B LITE GLOVE 1000/CASE 571711 manufactured by Covidien.
[65941843]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[65941844]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with lite gloves. The customer reports the lite gloves are breaking easily when installed on the light handles prior to surgery. The plastic material appears to be too weak and tears open. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2017-00032 |
| MDR Report Key | 6274368 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2017-01-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NS-3600-B LITE GLOVE 1000/CASE |
| Generic Name | LITE GLOVE |
| Product Code | FMC |
| Date Received | 2017-01-24 |
| Model Number | 571711 |
| Catalog Number | 571711 |
| Lot Number | 6159106364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-24 |