MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-27 for BARIBRIEF manufactured by Medline Industries Inc..
[131513572]
The end-user notified the manufacturer that she felt the brief had decreased absorbency. Reportedly, she went to a local hospital's emergency department with a fever, and "welts and rashes" to the brief site. She was diagnosed with a urinary tract infection and admitted to the hospital. The end-user stated that during her hospital stay she received unidentified antibiotics and was required to have an unidentified surgical procedure for a "kidney infection. " reportedly, the end-user also required in-home azactam antibiotic therapy after she was discharged from the hospital. The end-user did not provide the manufacturer with a lot number and indicated that no samples were available to be returned to the manufacturer for evaluation. A root cause for the reported incident could not be determined. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[131513573]
It was reported that the end-user experienced a urinary tract infection, was admitted to the hospital, and required unidentified antibiotics and an unidentified surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00144 |
| MDR Report Key | 8199550 |
| Report Source | OTHER |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2018-12-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BRIEF,BARIATRIC,65-94",BEIGE,32/CS,4/8'S |
| Product Code | EYQ |
| Date Received | 2018-12-27 |
| Catalog Number | BARIBRIEF |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-12-27 |