MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-12 for ADAPT PASTE 79300 manufactured by Hollister Incorporated.
[3547285]
It was reported that over a period of 3-4 months, the user noted skin infection and serous leakage under the ostomy barrier in the area where adapt skin barrier paste was used. He went to the doctor and was prescribed oral antibiotics. The area started to clear up but then became worse. On (b)(6) 2013, he was hospitalized and iv medication was administered. The medication received is unknown but the drainage was clearing up while he was in the hospital and not using adapt past. He was discharged from the hospital and began to use adapt paste again with a noted increase in drainage around the stoma. He went back to the hospital where they treated him again and instructed him to stop using the adapt paste. No allergy testing was performed and it is unknown what type of infection or reaction he was having.
Patient Sequence No: 1, Text Type: D, B5
[10782302]
Without the sample, the reported incident is unable to be fully evaluated. The ifu states "do not apply to severely irritated or eroded skin, open cuts or sores. " the patient continued to use the product until the hospital told him not to at his last visit. Should additional information become available, it will be reviewed and a follow up report submitted as needed. Hollister will continue to monitor the product's performance for any trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119193-2013-00012 |
| MDR Report Key | 3166202 |
| Report Source | 04 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-06-12 |
| Date of Event | 2013-05-01 |
| Date Mfgr Received | 2013-05-13 |
| Date Added to Maude | 2013-06-13 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNE RIBA |
| Manufacturer Street | 2000 HOLLISTER DR |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476805625 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 366 DRAFT AVE |
| Manufacturer City | STUARTS DRAFT VA 24477 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24477 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADAPT PASTE |
| Generic Name | ADAPT SKIN BARRIER PASTER |
| Product Code | EZR |
| Date Received | 2013-06-12 |
| Catalog Number | 79300 |
| Lot Number | 2H072 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DR LIBERTYVILLE IL 60048 US 60048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-06-12 |