MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for CURITY EYE PD 1-5/8X2-5/8 OVAL STRL 2841 manufactured by Covidien.
[66932422]
Submit date: 2/7/17. A device history record review was completed for lot# 91316100 produced on machine eye pad. There were no manufacturing related issues related to the complaint issued for this lot and the product was release accomplishing all quality standards. A sample was returned and visual inspection did confirm pad in the seal. During the process of running, the operator did not detect the pad in the seal due to only the bottom layer of the gauze was struck in the seal. This complaint will be shared with the manufacturing associates to heighten awareness of this defect. No changes to the quality control sampling plans are deemed necessary. Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures. No formal corrective action/preventive action has been created for this complaint. This complaint will be used for trending purposes and reviewed with plant management.
Patient Sequence No: 1, Text Type: N, H10
[66932423]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with an eye gauze pad. Customer states: the gauze had been sealed with the package causing not to be taken out. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2017-00018 |
| MDR Report Key | 6308647 |
| Date Received | 2017-02-07 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-12-08 |
| Date Mfgr Received | 2011-12-12 |
| Date Added to Maude | 2017-02-07 |
| 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 ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CURITY EYE PD 1-5/8X2-5/8 OVAL STRL |
| Generic Name | EYE GAUZE PAD |
| Product Code | HMP |
| Date Received | 2017-02-07 |
| Model Number | 2841 |
| Catalog Number | 2841 |
| Lot Number | 91316100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |