MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-09 for MEN'S LIBERTY EXTERNAL MALE CATHETER 23046 manufactured by Bioderm, Inc..
[4776056]
Report received from care giver on (b)(6) 2014 that customer had been discharged from the hosp that day. Care giver stated that on (b)(6) 2014 her pt (our customer) had complained of burning on urination and care giver scheduled an appointment with the physician for (b)(6) 2014. While at the physician's office, the physician wanted a urine sample but did not want to remove the liberty catheter and asked the care giver to collect the sample the next day. The next day, the care giver went to the house to collect the sample and found the pt febrile and confused. She called the physician and described the symptoms and the physician ordered medical transport to the hosp for eval. The care giver states the emergency dept physician diagnosed the customer with pneumonia and urinary tract infection and admitted the customer to the hosp for treatment on (b)(6) 2014. Caregiver reports a hosp stay until (b)(6) 2014. Customer was discharged to home on (b)(6) 2014. There was not a discharge to a rehabilitation facility needed for the customer. The customer had a picc line inserted at the hosp and the caregiver was trained to administer iv antibiotics, 1 gram ceftriaxone (rocephin) qd. The customer will be followed by a home health nurse also. At the time of our conversation with the care giver and the customer on (b)(6) 2014 the customer was afebrile at home and ambulatory with a walker. Care giver states he is recovering well. At the time of our conversation with the caregiver on (b)(6) 2014, the physician has discontinued iv therapy and placed the customer on po antibiotics. Caregiver states the customer is "walking around and doing very well" with home health physical therapy.
Patient Sequence No: 1, Text Type: D, B5
[11933877]
Customer has used liberty since (b)(6) 2013 with no reports of previous problems related to the men's liberty. An examination of the complaint file indicates that there are no other complaints associated with this lot number. At this time there is no evidence of a causal relationship between the men's liberty external catheter and this event experienced by the customer. Medical records have been requested from health care providers. As soon as medical records are reviewed by the bioderm medical consultant, we will file a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063299-2014-00001 |
| MDR Report Key | 4006371 |
| Report Source | 04 |
| Date Received | 2014-08-09 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-07-12 |
| Date Mfgr Received | 2014-07-16 |
| Device Manufacturer Date | 2014-05-16 |
| Date Added to Maude | 2014-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BILL COSNER |
| Manufacturer Street | 12320 73RD COURT NORTH |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7275077655 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEN'S LIBERTY EXTERNAL MALE CATHETER |
| Generic Name | LIBERTY EXTERNAL CATHETER |
| Product Code | NOA |
| Date Received | 2014-08-09 |
| Model Number | 23046 |
| Catalog Number | 23046 |
| Lot Number | Z13601 |
| ID Number | NA |
| Device Expiration Date | 2016-09-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODERM, INC. |
| Manufacturer Address | 12320 73RD COURT NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2014-08-09 |