MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-09-07 for SUR-FIT NATURA DURAHESIVE MOLDABLE BARRIER 404593 manufactured by Convatec.
[684660]
Reported by the complainant as follows. The original trial of convex moldable skin barriers (sent to her end of may/2007) had gone well, and she then purchased a box of the product. She had used about 5 skin barriers from the box when the problems started. It was because she developed a fever of 40 c and had blood in urine and abdominal pain that she sought treatment in the emergency room. She has now finished the antibiotics, the urine is clear and she has no more abdominal discomfort and no fever. She felt that the uti was caused by the moldable convex product. She stated "the material squeezed the stoma and i noticed there was less urine in the bag".
Patient Sequence No: 1, Text Type: D, B5
[8123625]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2007-00019 |
| MDR Report Key | 908735 |
| Report Source | 04 |
| Date Received | 2007-09-07 |
| Date of Report | 2007-08-29 |
| Date of Event | 2007-07-24 |
| Date Mfgr Received | 2007-07-24 |
| Date Added to Maude | 2007-09-12 |
| 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 DR. |
| 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 | SUR-FIT NATURA DURAHESIVE MOLDABLE BARRIER |
| Generic Name | APPLIANCE, COLOSTOMY, DISPOSABLE |
| Product Code | EZS |
| Date Received | 2007-09-07 |
| Model Number | NA |
| Catalog Number | 404593 |
| Lot Number | NA |
| 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 | 883898 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-07 |