MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for RAYTEC SPONGE manufactured by Medline Industries, Inc.
[181770019]
The raytec: sponge unraveled during the surgery while being used within the patient; fragments of the sponge had to be removed from the patient. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093392 |
| MDR Report Key | 9774510 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-30 |
| Date Added to Maude | 2020-03-02 |
| 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 | 3 |
| Brand Name | RAYTEC SPONGE |
| Generic Name | GAUZE, SPONGE, INTERNAL X-RAY DETECTABLE |
| Product Code | GDY |
| Date Received | 2020-02-28 |
| Lot Number | 19KBV286 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |