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.
[67121277]
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. A visual observation was made and the reported issue was discovered. Product was found in the seal of the paper preventing the sealing unit from sealing the package correctly. Corrective actions/preventative actions are not required due to the very low trend and this happening over 3 years ago no formal or corrective action put in place at this time. This complaint will be used for trending purposes and reviewed with plant management.
Patient Sequence No: 1, Text Type: N, H10
[67121278]
The customer reported the issue: prior to use on a patient, package was found open. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2017-00022 |
| MDR Report Key | 6308876 |
| Date Received | 2017-02-07 |
| Date of Report | 2015-04-09 |
| Date Mfgr Received | 2015-04-09 |
| 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 | 120002752562X |
| 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 |