MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-01-11 for SUR-FIT NATURA UROSTOMY POUCH 401534 manufactured by Convatec.
[551189]
Reported by the complainant as follows... Client received her script order and advises that as soon as it came into the house she could smell latex. When the box was opened she says "latex was over everything inside. " her eyes and throat swelled and she had to go to hosp for treatment; her father was available to take her there immediately. When the boxes were opened (after treatment), she advises the pouches were packed in plastic bags - she is not aware of having received them like this previously.
Patient Sequence No: 1, Text Type: D, B5
[8056957]
All products mentioned in this case are latex free. Convatec's investigation has confirmed that products were made within specification and excluded any possibility of latex glove use in the mfg, packaging, or dispatch of product. This remains a serious reaction, however, convatec is confident that there was no relationship with our product. Case is being reported to the fda as a due diligence measure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2007-00001 |
| MDR Report Key | 805242 |
| Report Source | 04 |
| Date Received | 2007-01-11 |
| Date of Report | 2006-12-12 |
| Date of Event | 2006-12-11 |
| Date Mfgr Received | 2006-12-11 |
| Date Added to Maude | 2007-01-18 |
| 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 | 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA UROSTOMY POUCH |
| Generic Name | OSTOMY POUCH |
| Product Code | EZS |
| Date Received | 2007-01-11 |
| Model Number | NA |
| Catalog Number | 401534 |
| Lot Number | 6H10400 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 792754 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT NATURA UROSTOMY POUCH |
| Baseline Generic Name | OSTOMY POUCH |
| Baseline Model No | NA |
| Baseline Catalog No | 401534 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-01-11 |