MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-04-01 for NYLATEX 2 1/2X36 PKG OF 3 1204 manufactured by Chattanooga Group.
[1056688]
Customer received a severe rash after wearing a nylatex band. The customer wrote by letter: "i developed a severe rash directly under the band. It was severe enough that i had to visit a dermatologist for a final cure. What is puzzling to me, is that i have worn the same belts for several years with absolutely no problem. I admit that i should have written sooner but, is it possible that some type of new ingredient has been added to the composition of these belts. We are enclosing one of them, and if you need an old one to compare it with, please let me know". The customer uses the wrap to hold tissue in place in the abdomen area. The lose tissue is a resultant of the customer's abdominal bowel removal system. The customer wears the wrap continuously around his abdomen.
Patient Sequence No: 1, Text Type: D, B5
[8176656]
The customer confirmed that he had a similar rash approximately 10 months ago. Both rashes encompassed the circumference of his abdomen and the width of the wrap. In the most recent event, the customer sought medical attention from a dermatologist. The dermatologist prescribed prednisone and ointment. The rash reportedly cleared up after 5 to 10 days. The customer confirmed that there had been no change in hygiene products, to include cologne. The diet does not vary extensively. Some of the medication for the customer had changed prior to the event. The customer expressed that these events did not contribute to the event. The customer continues to use the wraps. The wrap was evaluated. The wrap appeared in good condition. No other patient events for this product part number is known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00103 |
| MDR Report Key | 1355323 |
| Report Source | 04 |
| Date Received | 2009-04-01 |
| Date of Report | 2009-03-19 |
| Date of Event | 2008-07-01 |
| Date Mfgr Received | 2009-03-19 |
| Date Added to Maude | 2009-04-09 |
| 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 | MR. MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NYLATEX 2 1/2X36 PKG OF 3 |
| Generic Name | NYLATEX 2 1/2X36 PKG OF 3 |
| Product Code | FSD |
| Date Received | 2009-04-01 |
| Model Number | 1204 |
| Catalog Number | 1204 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-01 |