MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for BARD HEYMAN FOLLOWER COUDE TIP 10 FR., STERILE 021310 manufactured by C.r. Bard, Inc. (covington) -1018233.
[105102293]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[105102294]
It was reported that the tip has been very blunt instead of having a smooth tapered end. This caused significant damage to urethral tissue. Per additional information from dr. (b)(6). There was no change in the medical management of the patient with more traumatic dilation (damage to urethral tissue) except to leave the post-dilation catheter in longer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-01156 |
| MDR Report Key | 7419320 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-06-22 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2018-04-10 |
| 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 | AMY GRAVLEY |
| 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 | 0 |
| Brand Name | BARD HEYMAN FOLLOWER COUDE TIP 10 FR., STERILE |
| Generic Name | DILATION CATHETER |
| Product Code | FBW |
| Date Received | 2018-04-10 |
| Returned To Mfg | 2018-03-23 |
| Catalog Number | 021310 |
| Lot Number | MCBV3102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-04-10 |