MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-09 for DYNC8552 manufactured by Medline Industries Inc.
[91512134]
The account reported that when the nurse placed the patient on the bedpan there was sharp plastic on the bedpan that cut the patients bottom while she was being placed on the pan. The nurse reported that the pan was intact and not cracked when being placed. The cut became infected and the patient developed cellulitis. The patient was treated with unknown intravenous (iv) antibiotic for approximately 6-8 weeks which extended the patients hospital stay. The reporter did not know the patients weight at the time of the event or comorbidities that may have contributed to the patient's cellulitis. The patient is home now and the cut has healed. A sample is not available to be returned for evaluation however, due to the reported incident and subsequent need for medical intervention, this medwatch is being filed. If additional relevant information becomes available this report will be reopened and reevaluated. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[91512135]
The account reported the edges of the pan are very sharp plastic and it cut the patient's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00079 |
| MDR Report Key | 7014734 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-11-09 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Manufacturer G1 | MEDLINES INDUSTRIES INC |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BEDPAN,MEGA-FRACTURE,GRAPHITE, BARIATRIC |
| Product Code | FOB |
| Date Received | 2017-11-09 |
| Catalog Number | DYNC8552 |
| Lot Number | UNK |
| Operator | NURSE |
| 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 DR NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-11-09 |