MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for COVIDIEN CURITY manufactured by Covidien Llc.
[59872808]
Cotton ball used in covidien iodoform packing strips packaging was unknowingly placed in pt with the packing strip. When packing strip was removed from pt for wound vac placement, cotton ball was not visualized-believed to have travelled deeper, but was found when infection was cleaned and cotton ball was removed after wound vac used to assist wound healing. Cotton ball not sent to lab, was removed in physician office. Dose or amount: small cotton ball, frequency: 1, route: packed with packing strip. Event abated after use stopped or dose reduced: yes. Diagnosis or reason for use: pacemaker adjustments. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065966 |
| MDR Report Key | 6098770 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-02 |
| Date of Event | 2016-09-16 |
| Date Added to Maude | 2016-11-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COVIDIEN CURITY |
| Generic Name | IODOFORM PACKING STRIP |
| Product Code | GER |
| Date Received | 2016-11-09 |
| Lot Number | 16H084862 |
| Device Expiration Date | 2018-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-11-09 |