MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-04 for CENTER POINT LOCK TWO-PIECE OSTOMY SYSTEM PREMIER SERIES CUT 44MM (1 3/4) * manufactured by Hollister, Inc..
[19256870]
Rptr writes, "this morning i donned a fresh referenced hollister two piece ostomy system over my colostomy. Seven hrs later the system failed. Fortunately i was home then because feces seeped under the lower portion (6 o'clock) of the barrier and the tape. My body and clothes were soiled. When i removed the prosthesis, totality of the failure of the skin barrier was obvious; feces seeped under, covered the entire surface of the flextend skin barrier. Although hollister makes no claims for its intended purpose, performance characteristics or quality, it is marketed for ostomy use and therefore carries an implied warranty of functionality. It is obvious that the referenced item did not perform its implied function of adhesion and provide a secure seal for me. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016462 |
| MDR Report Key | 226297 |
| Date Received | 1999-06-04 |
| Date of Report | 1999-05-25 |
| Date of Event | 1999-05-25 |
| Date Added to Maude | 1999-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTER POINT LOCK TWO-PIECE OSTOMY SYSTEM PREMIER SERIES CUT |
| Generic Name | OSTOMY SYSTEM |
| Product Code | EZS |
| Date Received | 1999-06-04 |
| Model Number | 44MM (1 3/4) |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 9B052 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 219447 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 2000 HOLLISTER DR. LIBERTYVILLE IL 60048 US |
| Brand Name | FLEXTEND SKIN BARRIER WITH ELASTAFLEX BACKING, TAPE, FLANGE |
| Generic Name | SKIN BARRIER |
| Product Code | EZS |
| Date Received | 1999-06-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 9B052 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 219448 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 2000 HOLLISTER DR. LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-06-04 |