MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-11-20 for STOMAHESIVE PROTECTIVE POWDER 183910 manufactured by Convatec.
[750090]
Reported by the complainant as follows... Customer has used stomahesive paste for years. Customer asks whether the composition has changed, and if it could have caused an allergic reaction, and should the use of the product to be discontinued. This case was closed as a non-serious ae based on the facts presented by the end-user at the time. A follow up note was added to the case after it was closed indicating the end user experienced anaphylactic reaction and sought medical attention in a hospital on three occasions. This new information now changes the category of this event to a serious event. Causality is unknown; although the end user believes the three events to be related to stomahesive paste, there is not enough information to categorically determine this.
Patient Sequence No: 1, Text Type: D, B5
[8040338]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2007-00026 |
| MDR Report Key | 951506 |
| Report Source | 04,05 |
| Date Received | 2007-11-20 |
| Date of Report | 2006-09-25 |
| Date of Event | 2006-09-25 |
| Date Mfgr Received | 2006-09-25 |
| Date Added to Maude | 2007-11-28 |
| 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 DRIVE |
| 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 | STOMAHESIVE PROTECTIVE POWDER |
| Generic Name | OSTOMY PROTECTOR |
| Product Code | EZS |
| Date Received | 2007-11-20 |
| Model Number | NA |
| Catalog Number | 183910 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 923911 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-20 |