MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-13 for CAPRI BLADDER CONTROL PADS manufactured by Medline Industries Inc..
[62825474]
Here's what i sent to (b)(6) on (b)(6) message about the situation: i have another issue with another bladder control pad. I found this one on here when i took this out of the wrapper. It's not even fair to me to have these kinds of issues with these products again. It looks like someone used it (a tissue or something it's gross and disturbing). They replied back about my number and about someone contacting me which no one has. The first message about it went out on sunday (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066738 |
| MDR Report Key | 6185090 |
| Date Received | 2016-12-13 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-12-10 |
| Date Added to Maude | 2016-12-19 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPRI BLADDER CONTROL PADS |
| Generic Name | CAPRI BLADDER CONTROL PADS |
| Product Code | KME |
| Date Received | 2016-12-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-13 |