MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for NOVAPLUS STANDARD O.R. TOWELS V724-B manufactured by Medical Action Ind., Inc..
[138508057]
Received operating room towels with a slit in the package (contaminated). See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084815 |
| MDR Report Key | 8409918 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-22 |
| Date Added to Maude | 2019-03-11 |
| 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 | NOVAPLUS STANDARD O.R. TOWELS |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-03-11 |
| Catalog Number | V724-B |
| Lot Number | 1808JK402A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION IND., INC. |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |