MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-03 for * 13499-MAV manufactured by Cardinal Healthcare.
[345950]
Pt stated that after being placed on bedpan, it broke - 7 cm laceration to left buttock. (multiple issues with bedpans breaking under several pts).
Patient Sequence No: 1, Text Type: D, B5
[409898]
Add'l info rec'd from mfr 3/25/05: this product is manufactured by medegen, llc, 209 medegen dr. , gallaway, tn 38036. Cardinal neither manufacture nor own the regulatory pathway for this product. Cardinal distributes this product for medegen. Cardinal has copied them on request for info and has asked them to respond back directly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034687 |
| MDR Report Key | 575241 |
| Date Received | 2005-02-03 |
| Date of Report | 2005-02-02 |
| Date of Event | 2004-12-11 |
| Date Added to Maude | 2005-02-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | BEDPAN |
| Product Code | FOB |
| Date Received | 2005-02-03 |
| Model Number | 13499-MAV |
| Catalog Number | * |
| Lot Number | 4120504 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 565093 |
| Manufacturer | CARDINAL HEALTHCARE |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-03 |