MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-07-22 for CONVATEC LOOP OSTOMY ROD 022356 manufactured by Convatec.
[458428]
"it is a detachment of the swivel and (reported by surgeon because he did not find this small part of the loop when he examined the patient. ) and for information, the loop was used with the system easyflex 70 and not sutured. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00042 |
| MDR Report Key | 720249 |
| Report Source | 07 |
| Date Received | 2005-07-22 |
| Date of Report | 2005-07-22 |
| Date of Event | 2005-06-20 |
| Date Mfgr Received | 2005-06-23 |
| Date Added to Maude | 2006-05-31 |
| 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 HEADQUARTERS PARD DR |
| Manufacturer City | SKILLMAN NJ 08858 |
| Manufacturer Country | US |
| Manufacturer Postal | 08858 |
| 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 | 2005-07-22 |
| Returned To Mfg | 2005-07-13 |
| Model Number | NA |
| Catalog Number | 022356 |
| Lot Number | 4E78881 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 709318 |
| 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 | 022356 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-22 |