MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-02-23 for MMC SILICONE GEL SHEETING MMC-91 manufactured by Cui Corporation.
[87112]
Physician indicated that pt began to have signficiant blistering shortly after using gel sheeting. He believes that problem developed into full thickness skin necrosis due to secondary infection. Problem did not develop where sheeting was applied, but in areas nearby. Physician did not feel the device was involved, however he did not feel he could rule out the possiblity, so cui is reporting in good faith.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021296-1998-00001 |
| MDR Report Key | 151935 |
| Report Source | 08 |
| Date Received | 1998-02-23 |
| Date of Report | 1998-02-21 |
| Date of Event | 1998-01-04 |
| Date Mfgr Received | 1998-01-26 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1998-02-27 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MMC SILICONE GEL SHEETING |
| Generic Name | SILICONE GEL SHEETING |
| Product Code | MDA |
| Date Received | 1998-02-23 |
| Model Number | NA |
| Catalog Number | MMC-91 |
| Lot Number | 3-105061 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 148062 |
| Manufacturer | CUI CORPORATION |
| Manufacturer Address | 1160 MARK AVE CARPINTERIA CA 93013 US |
| Baseline Brand Name | MMC SILICONE GEL SHEETING |
| Baseline Generic Name | SILICONE GEL SHEETING |
| Baseline Model No | NA |
| Baseline Catalog No | MMC-91 |
| Baseline ID | NA |
| Baseline Device Family | SILICONE GEL SHEETING |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K913140 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-02-23 |