MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-01-21 for ROCHESTER MEC ULTRAFLEX M 30BX 33302 manufactured by C.r. Bard, Inc. (covington) -1018233.
[175712736]
The reported event was inconclusive, as the device was not returned for evaluation. A potential failure mode could be? Device is difficult to remove.? A potential root cause for this failure could be "adhesive is too strong. " the lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "precaution: do not use if allergic reaction occurs. For good hygiene, change catheter daily. Use of a single device for longer periods than 24 hours may increase the risk of complications. Directions: to apply: wash penis with mild soap and warm water. Dry thoroughly. Trim pubic hair if necessary. Unroll self-adhering catheter over penis. Gently squeeze the catheter to properly seal adhesive to the skin. Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin. Connect to drainage device. Directions: to remove gently roll catheter off the penis. "
Patient Sequence No: 1, Text Type: N, H10
[175712737]
It was reported that the product stuck too much to the patient's skin, and was hard to come off. No medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00455 |
| MDR Report Key | 9611337 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-21 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHESTER MEC ULTRAFLEX M 30BX |
| Generic Name | MEC |
| Product Code | NNX |
| Date Received | 2020-01-21 |
| Model Number | 33302 |
| Catalog Number | 33302 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |