MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for MEDICAL ACTION INDUSTRIES 75431 manufactured by Medical Action Industries Inc..
[109020991]
Patient Sequence No: 1, Text Type: N, H10
[109020992]
Rn obtained suture removal kit from supply room. Before opening kit, noticed inside kit a piece of debris attached to the hemostats in the kit. This kit remained unopened. Nurse reported it to safety officer. Entire package retained for review if needed. No harm to staff or patient, device package not opened, just noticed something debris-like attached to device. Not used. Manufacturer response for suture removal kit, suture removal kit (per site reporter). Will obtain for their observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7536687 |
| MDR Report Key | 7536687 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-04-20 |
| Report Date | 2018-05-17 |
| Date Reported to FDA | 2018-05-17 |
| Date Reported to Mfgr | 2018-05-17 |
| Date Added to Maude | 2018-05-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | PATIENT |
| 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 | 3 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | SUTURE REMOVAL KIT |
| Product Code | MCZ |
| Date Received | 2018-05-23 |
| Model Number | 75431 |
| Catalog Number | 75431 |
| Lot Number | 241424 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES INC. |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-23 |