MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-01-03 for OSTOMY ROD STERILE 1281201008 manufactured by Coloplast A/s.
[131964736]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131964737]
According to the available information, the patient had a sub-acute operation, implanted a loop-ileoostomy over an ostomy rod on (b)(6) 2018. Patient was checked by a doctor on (b)(6) 2018, where the loop-ileoostomy was intact and the ostomy rod was placed under the ostomy ridge. Ostomy rod was freely moving. Plan was made to bandage the stoma with the ostomy rod. Due to the rupture of the facie - patient was re-operated on (b)(6) 2018. During this operation, it was described that the stoma had a lesion of the backside. After the operation, it was described that the stoma was bleeding and that the stoma had "ruptured". It is not known, in which situation the ostomy rod has caused decay of the loop-ileoostomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2019-00002 |
| MDR Report Key | 8213566 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-01-03 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2019-01-03 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE BUMGARNER |
| Manufacturer Street | 1601 WEST RIVER ROAD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122630488 |
| Manufacturer G1 | COLOPLAST HUNGARY KFT |
| Manufacturer Street | COLOPLAST UTCA 2 SZABOLCS-SZATMAR-BEREG |
| Manufacturer City | NYIRBATOR, 4300 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 4300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTOMY ROD STERILE |
| Generic Name | ROD, COLOSTOMY |
| Product Code | EZP |
| Date Received | 2019-01-03 |
| Model Number | 1281201008 |
| Catalog Number | 1281201008 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, REGION HOVEDSTADEN 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-03 |