MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-08-09 for CURITY 7831 manufactured by Covidien.
[82333506]
Submit date: 8/9/2017. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[82333507]
The customer (patient) states that she got a staph infection from c-section in 2012. The customer states that the use of 'kendall curity iodoform packing material strip' was used out of date. The product expired on january 2008 and second bottle of same product used on the patient expired on june 2009.
Patient Sequence No: 1, Text Type: D, B5
[109288264]
Submit date: 5/25/2018. There were no samples received with this complaint therefore an examination of the reported issue could not be made. A review of the device history record was not performed during this investigation as the lot number was not received with the complaint. All device history records are reviewed and approved by quality prior to release of product. Because there was no lot number, a date of manufacture could not be determined. Since this complaint will be considered unconfirmed, no corrective or preventive actions will be taken at this time. If additional information or samples are received, the investigation will resume as needed. This complaint will be used for trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2017-05070 |
| MDR Report Key | 6778447 |
| Report Source | OTHER |
| Date Received | 2017-08-09 |
| Date of Report | 2018-05-25 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-08-09 |
| 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 | 1647 PERKINS RD |
| Manufacturer City | AUGUSTA GA 30913 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30913 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2017-08-09 |
| Model Number | 7831 |
| Catalog Number | 7831 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1647 PERKINS RD AUGUSTA GA 30913 US 30913 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-09 |