MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; BEDPAN,MEGA-FRACTURE,GRAPHITE, BARIATRIC

Catalog Number DYNC8552

Device Problems Material Distortion (2977); Material Integrity Problem (2978)

Patient Problem Cellulitis (1768)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The account reported the edges of the pan are very sharp plastic and it cut the patient's skin.

• Type of Device: BEDPAN,MEGA-FRACTURE,GRAPHITE, BARIATRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; three lakes dr; northfield IL 60093
• Manufacturer (Section G): MEDLINES INDUSTRIES INC; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7014734
• MDR Text Key: 91512134
• Report Number: 1417592-2017-00079
• Device Sequence Number: 1
• Product Code: FOB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: DYNC8552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization