MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-19 for DIAMONDS ODOR CTRL TR105 (1X100 JAR) 420791 manufactured by Convatec Limited.
[57877294]
Based on the available information, this event is deemed to be a serious injury. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Reported to the fda on october 19, 2016. (b)(4). Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[57877295]
It was reported that an ostomized patient, who is a frequent user of the diamonds sachets, went to the medical service with diarrhea and a nurse opened the sachet and poured its contents into the patient's stoma. Per additional information received on october 10, 2016 bowel pumping was performed on the patient. Patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2016-00083 |
| MDR Report Key | 6041597 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-26 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2013-12-18 |
| Date Added to Maude | 2016-10-19 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | DIRECTOR, QUALITY COMPLAINT HANDLING UNIT, 7900 TRIAD CTR |
| Manufacturer City | DR., STE 400 GREENSBORO, NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMONDS ODOR CTRL TR105 (1X100 JAR) |
| Generic Name | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2016-10-19 |
| Model Number | 420791 |
| Lot Number | T02250 |
| Device Expiration Date | 2017-11-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-19 |