MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for NOVA10145 manufactured by Medline Industries, Inc..
[52946410]
It was reported that the bedpan collapsed when the nurse placed a post op burn patient on it in the pacu. As a result, urine spilled in the bed and caused her new surgical dressings to become wet. The surgeon came and replaced the dressings. No other information was provided. The weight of the patient is not known. The sample was not returned for evaluation. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
[52946411]
The bedpan collapsed under the patient causing the surgical dressing to become wet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00091 |
| MDR Report Key | 5901660 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-08-24 |
| 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 | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BEDPAN |
| Product Code | FOB |
| Date Received | 2016-08-24 |
| Catalog Number | NOVA10145 |
| Lot Number | UNK |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-24 |