MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-04-17 for PASTA STRIPS 5 PC 0265501001 manufactured by Coloplast A/s.
[844758]
According to the information received, a 6-month old stomy patient was infected by mucor. Patient treated with ambisome, and treatment of fungal infection was successful. Patient condition is still critical, but stable. Hospital laboratory testing of two product samples identified mucor on both. Coloplast testing of product from referenced lot identified aspergillus.
Patient Sequence No: 1, Text Type: D, B5
[8061533]
Samples from the same lot were examined. Microbial testing confirmed presence of aspergillus in all samples. Production documentation was reviewed from raw materials through finished product. The review indicated that the product complied with specifications and qa system requirements. Product is not intended to be sterile and is not labeled as sterile. Additional testing is ongoing, and a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610694-2008-00001 |
| MDR Report Key | 1031160 |
| Report Source | 01 |
| Date Received | 2008-04-17 |
| Date of Report | 2008-03-18 |
| Date of Event | 2008-03-01 |
| Date Mfgr Received | 2008-03-18 |
| Device Manufacturer Date | 2007-11-19 |
| Date Added to Maude | 2008-04-24 |
| 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 | REBEKA STOLTMAN, MANAGER, |
| Manufacturer Street | 1499 WEST RIVER ROAD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | HOLTEDAM 1 |
| Manufacturer City | HUMLEBAEK |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASTA STRIPS 5 PC |
| Generic Name | OSTOMY PASTE |
| Product Code | EZS |
| Date Received | 2008-04-17 |
| Returned To Mfg | 2008-03-30 |
| Model Number | 0265501001 |
| Catalog Number | 0265501001 |
| Lot Number | 1329646 |
| Device Expiration Date | 2010-11-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 999847 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-04-17 |