MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2010-10-21 for SUR-FIT NATURA DURAHESIVE SKIN BARRIER 411800 manufactured by Convatec Dr Inc..
[1756941]
Reported by the complainant as follows: father was admitted into the hospital with a "necrotic" stoma. He is wearing the moldable and she wanted to know if it would have been caused by the manner in which the moldable was installed. He has been using the moldable for 1. 5 years with no problems. He was placed in a home as he has alzheimer's. She finds that the staff does not listen to her and she saw one nurse roll the material under instead of upwards. Suggested going into a cut-to-fit product so that there would be no issue. His stoma is now larger but not sure if it was larger at the time that the "necrosis" started or the inflammation started after. The "necrosis" is now gone-took over 2 weeks to heal and she does not want it to reoccur. Stoma now measures larger than 22mm. The patient was brought to the emergency room at the request of the stomal therapist. There was no bleeding. The stoma measures 22mm and was wearing the sur-fit natura durahesive skin barrier. The stoma is a little larger at the top than at the bottom. The client was put on antibiotics in the er and the "necrosis" healed up after 3 days. They did an x-ray and blood tests to rule out peritonitis and everything was fine. He has completed the antibiotics since sunday and no further discoloration of the stoma has been noted.
Patient Sequence No: 1, Text Type: D, B5
[8743532]
(b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2010-00045 |
| MDR Report Key | 1882501 |
| Report Source | 04,07 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-09-27 |
| Date of Event | 2010-09-06 |
| Date Mfgr Received | 2010-09-27 |
| Date Added to Maude | 2010-10-28 |
| 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 | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA DURAHESIVE SKIN BARRIER |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | FON |
| Date Received | 2010-10-21 |
| Model Number | NA |
| Catalog Number | 411800 |
| Lot Number | UNK |
| 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 | CONVATEC DR INC. |
| Manufacturer Address | CARRETERA SANCHEZ, KM. 18.2 PARQUE INDUSTRIAL ITABO, S.A. HAINA 33102 DR 33102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-21 |