MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-06-25 for DIAMOND TOUCH SILICONE SHEETING 89-8529 manufactured by Genzyme Biosurgery A Div Of Ge.
[18192656]
The complainant alleged an allergic reaction following the use of silicone sheeting. The silicone sheeting was used to treat heat burns with scarring. The product had been used since 2000 without complication. Following 30 hrs of continuous use, the complainant alleged experiencing a severe rash (all red) and rough skin which was flaking. In addition, three of the four wound areas were properly healed prior to initial application; the fourth still exhibiting redness. The fourth area was the first area to show signs of the reported reaction, with the remaining areas following.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221601-2001-00001 |
| MDR Report Key | 339446 |
| Report Source | 04 |
| Date Received | 2001-06-25 |
| Date of Report | 2001-06-25 |
| Date of Event | 2001-06-15 |
| Date Mfgr Received | 2001-06-15 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2001-06-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DENISE LIMA |
| Manufacturer Street | 600 AIRPORT ROAD |
| Manufacturer City | FALL RIVER MA 02720 |
| Manufacturer Country | US |
| Manufacturer Postal | 02720 |
| Manufacturer Phone | 5086776600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMOND TOUCH SILICONE SHEETING |
| Generic Name | SILICONE SHEETING |
| Product Code | MDA |
| Date Received | 2001-06-25 |
| Model Number | 89-8529 |
| Catalog Number | 89-8529 |
| Lot Number | 21265E |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 328772 |
| Manufacturer | GENZYME BIOSURGERY A DIV OF GE |
| Manufacturer Address | 600 AIRPORT RD. FALL RIVER MA 02720 US |
| Baseline Brand Name | DIAMOND TOUCH SILICONE SHEETING |
| Baseline Generic Name | SILICON SHEETING 4.0 X 8.0 |
| Baseline Model No | 89-8529 |
| Baseline Catalog No | 89-8529 |
| Baseline ID | NA |
| Baseline Device Family | US |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971468 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-25 |