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.
[67115906]
A device history record is generated for the lot of the product meeting all acceptance criteria prior to release. By looking at the samples it looks as if the product was not cut correctly on the die therefore it was left oblong, which caused it to get caught in the sealing section of the package. With this being a low trending issue, there will not be any formal corrective action/preventative action at this time. This reported condition will be used for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
[67115907]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with an eye gauze pad. The customer states: prior to use on a patient, the pad was sealed with package. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2017-00021 |
| MDR Report Key | 6308835 |
| Date Received | 2017-02-07 |
| Date of Report | 2014-07-14 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-07-14 |
| 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 | 110002214462 |
| 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 |