MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-11-01 for MEN'S LIBERY EXTERNAL MALE CATHETER 23046 manufactured by Bioderm, Inc..
[4974406]
Care giver reports hospitalization for sepsis, (b)(6) 2014. Discharged (b)(6) 2014. This report was made to bioderm on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[12600037]
Bioderm device history file for lot number z16101 has been reviewed by regulatory affairs and found to be within specifications. Complaint files have been reviewed for any add'l complaints for that lot number and none exist. Customer and caregiver have been asked to sign a release of medical records but have declined until they see the attending urologist in mid (b)(6). As soon as the customer determines that he will sign a release, we will request records. Then as soon as we receive the records we will initiate a review with our medical consultants and close this report. If the request is denied by the customer, we will close based on the current data. At this point, there is no evidence to indicate that the men's liberty was causal to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063299-2014-00002 |
| MDR Report Key | 4223714 |
| Report Source | 04 |
| Date Received | 2014-11-01 |
| Date of Report | 2014-10-30 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-10-07 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-11-05 |
| 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 LIBERY EXTERNAL MALE CATHETER |
| Generic Name | LIBERY EXTERNAL CATHETER |
| Product Code | NOA |
| Date Received | 2014-11-01 |
| Model Number | 23046 |
| Catalog Number | 23046 |
| Lot Number | Z16101 |
| ID Number | NA |
| Device Expiration Date | 2016-12-30 |
| 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 | 2014-11-01 |