MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,08 report with the FDA on 2011-08-29 for RUSCH PUREGOLD COUDE 2WPTFE 30C 318320 manufactured by Teleflex Medical.
[18614555]
The event is reported as: alleged issue per end user: the catheter bubble did not stay inflated. Requested additional information.
Patient Sequence No: 1, Text Type: D, B5
[18745665]
Unknown if sample is available for evaluation, therefore, investigation is incomplete. A follow-up investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2011-00125 |
| MDR Report Key | 2257482 |
| Report Source | 04,07,08 |
| Date Received | 2011-08-29 |
| Date of Report | 2011-08-18 |
| Date Mfgr Received | 2011-08-18 |
| Date Added to Maude | 2011-11-16 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | P.O. BOX 28 |
| Manufacturer City | KAMUNTING, PERAK |
| Manufacturer Country | MY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH PUREGOLD COUDE 2WPTFE 30C |
| Generic Name | BLADDER CATHETER |
| Product Code | KOB |
| Date Received | 2011-08-29 |
| Catalog Number | 318320 |
| Lot Number | 11C05 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-29 |