MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for URODYNAMICS BALLOON CATHETER 020707-B5 manufactured by Cook Inc.
[129593400]
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[129593401]
It was reported that during the use of urodynamics balloon catheter for cystometry studies, the balloon "exploded". It was further noted that the balloon material was split from proximal bond to distal bond. There were no adverse effects reported due to the event and no report of an additional procedure. A new product was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03581 |
| MDR Report Key | 8116653 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2016-07-18 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2015-12-11 |
| Date Added to Maude | 2018-11-29 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | URODYNAMICS BALLOON CATHETER |
| Generic Name | FAP CYTOMETRIC GAS (CARBON DIOXIDE |
| Product Code | FAP |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2017-05-30 |
| Model Number | NA |
| Catalog Number | 020707-B5 |
| Lot Number | 6447907 |
| Device Expiration Date | 2018-12-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |