MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-13 for CONVATEC LOOP OSTOMY ROD 22355 manufactured by Convatec.
[15559309]
This case was discovered during the analysis of malfunction report 1049092-2005-00030 which was submitted in 05/2005. That case mentioned the occurrence of this event which was not previously reported to convatec. Nurse stated this event occurred "within the past year". The swivel tip separated from the rod while the rod was sutured in place. The pt's abdomen had become very distended and the rod came apart. Nurse stated that it was not considered an issue at the time and, as a result, was not reported to convatec.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00031 |
| MDR Report Key | 603095 |
| Report Source | 05 |
| Date Received | 2005-05-13 |
| Date of Report | 2005-05-12 |
| Date of Event | 2004-04-29 |
| Date Mfgr Received | 2005-04-29 |
| Date Added to Maude | 2005-05-18 |
| 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 | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUATERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVATEC LOOP OSTOMY ROD |
| Generic Name | OSTOMY ROD |
| Product Code | EZP |
| Date Received | 2005-05-13 |
| Model Number | NA |
| Catalog Number | 22355 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 592928 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR SKILLMAN NJ 08558 US |
| Baseline Brand Name | CONVATEC LOOP OSTOMY ROD |
| Baseline Generic Name | OSTOMY ROD |
| Baseline Model No | NA |
| Baseline Catalog No | 22355 |
| Baseline ID | NA |
| Baseline Device Family | OSTOMY ROD |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K811240 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-13 |