MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-12 for MEDICHOICE * ABB3P45 manufactured by Owens & Minor.
[5454568]
Red rash developed where abdominal binder had been.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4588984 |
| MDR Report Key | 4588984 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-02-04 |
| Report Date | 2015-02-12 |
| Date Reported to FDA | 2015-02-12 |
| Date Reported to Mfgr | 2015-03-11 |
| Date Added to Maude | 2015-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE |
| Generic Name | ABDOMINAL BINDER |
| Product Code | FSD |
| Date Received | 2015-02-12 |
| Model Number | * |
| Catalog Number | ABB3P45 |
| Lot Number | 261142-20141230 |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-12 |