MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-17 for DRAIN BAG W/SPLASHGUARD/ NO ANTIREFLUX 3057 manufactured by Covidien.
[2719581]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a urology drain bag. Customer reports that the urine is backing up in the tubing and is not draining into the bag. The customer further reports that a pt had increased blood pressure as a result and required an additional amount of blood pressure medication to be administered; however, they do not know the name of the medication. The pt status is fine.
Patient Sequence No: 1, Text Type: D, B5
[9934535]
Submit date: (b)(6) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2012-00027 |
| MDR Report Key | 2584569 |
| Report Source | 06 |
| Date Received | 2012-05-17 |
| Date of Report | 2012-04-19 |
| Report Date | 2012-04-19 |
| Date Reported to Mfgr | 2012-04-19 |
| Date Mfgr Received | 2012-04-19 |
| Date Added to Maude | 2012-08-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | KARLA CALDERON |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618622 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | C. 9 SUR #125 CD. INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAIN BAG W/SPLASHGUARD/ NO ANTIREFLUX |
| Generic Name | UROLOGY DRAIN BAG |
| Product Code | FCN |
| Date Received | 2012-05-17 |
| Model Number | 3057 |
| Catalog Number | 3057 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | C.9 SUR#125 CD. INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-17 |