MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-04-18 for LOOP OSTOMY ROD 022355 manufactured by Convatec.
[2753525]
It was reported that the swivel end breaks into pieces when opened. No harm or injury to the pt was reported. This was deemed a serious malfunction because of the possible danger of a broken piece of the loop rod falling into the abdominal cavity during the surgical procedure when the stoma is treated which could require medical intervention to prevent serious injury. During a routine review of our complaint codes, which insures the robustness and sustained performance of the complaint handling process, it was discovered that this complaint code type ("broken cracked" for the loop ostomy rod) was captured as a "product issue" and that, in this case, this should have been captured as a potentially reportable malfunction, which may require medical intervention to prevent serious injury. This complaint code has since been updated accordingly in our complaint handling system. A retrospective search of our complaint records confirmed that this was the only potentially reportable malfunction, that no other previous complaints were captured as a "product issue" reported to the fda on april 18, 2012. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243969-2012-00025 |
| MDR Report Key | 2559791 |
| Report Source | 01,05,07 |
| Date Received | 2012-04-18 |
| Date of Report | 2012-04-18 |
| Date of Event | 2011-04-12 |
| Date Mfgr Received | 2011-04-19 |
| Date Added to Maude | 2012-09-12 |
| 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 | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOOP OSTOMY ROD |
| Generic Name | COLOSTOMY ROD |
| Product Code | EZP |
| Date Received | 2012-04-18 |
| Model Number | NA |
| Catalog Number | 022355 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2012-04-18 |