MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for UNIVERSAL CLIPPER ATTACHMENT BLADE DYND70880 manufactured by Medline Industries (north Point Services).
[146230324]
During the c-section, 2 razor heads broke in two places. Report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086864 |
| MDR Report Key | 8636689 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-05-16 |
| Date Added to Maude | 2019-05-23 |
| 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 | UNIVERSAL CLIPPER ATTACHMENT BLADE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2019-05-22 |
| Model Number | DYND70880 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES (NORTH POINT SERVICES) |
| Manufacturer Address | WINNETKA IL 60093 US 60093 |
| Brand Name | UNIVERSAL CLIPPER ATTACHMENT BLADE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2019-05-22 |
| Model Number | DYND70880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES (NORTH POINT SERVICES) |
| Manufacturer Address | WINNETKA IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |