MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-07-02 for NEW IMAGE CONVEX SKIN BARRIER 14404 manufactured by Hollister, Inc..
[1411310]
It was reported that on (b)(6)2010 while removing an ostomy barrier that was well adhered, a small section of skin (2 lines on a ruler - between the inch markings) was stripped. The user noted that more than one layer of skin was removed but she was unsure how many. She believes it occurred due to the method she used (too strong) to remove the barrier. The area that was stripped had been previously irritated from fecal exposure that occurred when using a pre-sized appliance. On (b)(6)2010, the user went to the dr because the area was not healing correctly. She was given oral antibiotics and the area began to heal. Following the completion of the antibiotic prescription, the area again started getting irritated. The dr prescribed another course of antibiotics. On (b)(6)2010, she returned to the dr due to pain in the area. She was admitted to the hospital and put on iv antibiotics. She was told that the oral antibiotics were not working due to her high output stoma. She remained hospitalized from (b)(6) - (b)(6)2010. Following hospital release, pain again increased and she was hospitalized for iv antibiotics from (b)(6) - (b)(6)2010. She was discharged on (b)(6)2010 with a picc line for antibiotics and a wound dressing which she continues with today.
Patient Sequence No: 1, Text Type: D, B5
[8636821]
The user reported the event to a hollister nurse when the user was requesting assistance to determine a hollister product equivalent to the wound dressing she was given.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119193-2010-00002 |
| MDR Report Key | 1748938 |
| Report Source | 04 |
| Date Received | 2010-07-02 |
| Date of Report | 2010-07-06 |
| Date of Event | 2010-03-26 |
| Date Mfgr Received | 2010-06-07 |
| Date Added to Maude | 2010-07-12 |
| 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 Street | 2000 HOLLISTER DR. |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476805625 |
| Manufacturer G1 | HOLLISTER, INC. |
| Manufacturer Street | 366 DRAFT AVE. |
| Manufacturer City | STUARTS DRAFT VA 24477999 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24477 9998 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEW IMAGE CONVEX SKIN BARRIER |
| Generic Name | CONVEX FLEXWEAR BARRIER |
| Product Code | EZS |
| Date Received | 2010-07-02 |
| Catalog Number | 14404 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | LIBERTYVILLE IL 60048 US 60048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-07-02 |