MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-09-16 for SEPTI-SOFT CONCENTRATE (48BTLX8OZ) US 325309 manufactured by Convatec Inc..
[3742774]
Caller states she is caregiver for female who ingested one teaspoon of product. Declined to provide any demographics or personal info for caregiver or end user.
Patient Sequence No: 1, Text Type: D, B5
[11114248]
This is deemed a serious injury because medical intervention / treatment may be needed if this issue were to recur. From a preliminary clinical perspective, a casual relationship between the septi-soft - septi-soft concentrate and the event is deemed possible because product ingestion was temporally associated with the occurrence of the event. This issue has been reported to this company in the past and to date, no harmful after effects have been reported. A poison control center we have consulted also reported that the most severe outcome of ingesting the product are likely to be nausea, vomiting and diarrhea. Instructed caregiver on the side effects of ingestion. The caregiver was advised to follow up with doctor if any ill effects and to keep the product out of reach. No additional information has been provided to date. A return sample for evaluation is not expected. Reported to the fda on (b)(4) 2013. Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00088 |
| MDR Report Key | 3367710 |
| Report Source | 04,07 |
| Date Received | 2013-09-16 |
| Date of Report | 2013-08-16 |
| Date of Event | 2013-08-16 |
| Date Mfgr Received | 2013-08-16 |
| Date Added to Maude | 2013-09-26 |
| 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 | MARY SZARO |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEPTI-SOFT CONCENTRATE (48BTLX8OZ) US |
| Generic Name | SKIN CLEANSER |
| Product Code | KOY |
| Date Received | 2013-09-16 |
| Model Number | 325309 |
| Catalog Number | 325309 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-16 |