MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for MEDLINE - SURGICAL GOWN LEVEL 3 DYNJP2001S 0110080196304460 manufactured by Medline Industries.
[142879993]
Hair found in sterile pack of large surgical gown manufactured by medline. The gown was not used in the procedure. We have the gown. Date of manufacture: 12/15/2018. Gown opened for a surgical procedure and a hair was noted. Gown was removed from the room, reported to risk and quality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086036 |
| MDR Report Key | 8536073 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-04-09 |
| Date Added to Maude | 2019-04-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDLINE - SURGICAL GOWN LEVEL 3 |
| Generic Name | SIRUS SURGICAL GOWN |
| Product Code | FYA |
| Date Received | 2019-04-19 |
| Model Number | DYNJP2001S |
| Catalog Number | 0110080196304460 |
| Lot Number | (10)72518120009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |