MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-05 for manufactured by .
[84718729]
Brand name: ostomy-unknown wafer, common device name: protector, ostomy, product code: exe, manufacturer: convatec inc. (b)(4). Model#: ostomy-unknown wafer. Based on the available information, this event is deemed to be a serious injury. No lot number or product evaluation sample is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process. Additional information has been requested but nothing has been received to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84718730]
It was reported by the end user that she was provided convatec cut-to-fit wafers by her home care nurse sometime in 2006 or 2007 and when she cut them, the cut edges felt sharp. The end user reports she had a small amount of bleeding from her stoma and thinks it was caused by the sharp edge. The end user changed out the wafers to larger moldable ones and the bleeding resolved and has not recurred. No further harm was reported by the patient. No pictures were available and no further details have been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2017-00047 |
| MDR Report Key | 6842086 |
| Report Source | CONSUMER |
| Date Received | 2017-09-05 |
| Date Mfgr Received | 2017-08-18 |
| Date Added to Maude | 2017-09-05 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | EZS |
| Date Received | 2017-09-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-05 |