MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-03 for STR THOR CATH 28FR 8888570549 manufactured by Covidien.
[1390268]
It was reported to covidien on (b)(6) 2009 that a customer had a problem with a thoracic catheter. The customer reports that when they removed the thoracic drain, it was found to be broken and the patient had to be re-operated on to remove the broken piece of the drain. Patient condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
[8504589]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2009-00036 |
| MDR Report Key | 1556296 |
| Report Source | 06 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-11-09 |
| Report Date | 2009-11-09 |
| Date Reported to Mfgr | 2009-11-09 |
| Date Mfgr Received | 2009-11-09 |
| Date Added to Maude | 2010-09-20 |
| 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 | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| Manufacturer G1 | KENMEX |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA, CP 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STR THOR CATH 28FR |
| Generic Name | THORACIC CATHETER |
| Product Code | GBS |
| Date Received | 2009-12-03 |
| Model Number | 8888570549 |
| Catalog Number | 8888570549 |
| Lot Number | UNK |
| 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 | CALLE 9 SUR NO. 125 CUID TIJUANA, CP 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-03 |