MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for SUTURE REMOVAL KIT 06-6500 manufactured by Cardinal Health.
[28833399]
Operating room opened suture removal kit prior to coming in contact with patient and found debris on tweezer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057171 |
| MDR Report Key | 5161648 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-10-09 |
| Date of Event | 2015-10-05 |
| Date Added to Maude | 2015-10-20 |
| 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 |
| 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 | SUTURE REMOVAL KIT |
| Generic Name | SUTURE REMOVAL KIT |
| Product Code | MCZ |
| Date Received | 2015-10-09 |
| Catalog Number | 06-6500 |
| Lot Number | 399189 |
| Device Expiration Date | 2017-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-09 |