| BRAND NAME | SKIN PREP PROTECTIVE DRESSING |
|---|
| MANUFACTURER |
| SMITH AND NEPHEW UNITED |
| 11775 STARKEY RD. |
| LARGO FL 34649 |
|
| ACCESS NUMBER | M721230 |
|---|
| PRODUCT CODE | KOY |
|---|
| PANEL | GENERAL AND PLASTIC SURGERY |
|---|
| REPORT TYPE | SERIOUS INJURY |
|---|
| DATE FDA RECEIVED | 07/06/1995 |
|---|
| DEVICE CATALOGUE NUMBER | 4204-00 |
|---|
| EVENT DESCRIPTION TYPE | PRELIMINARY |
|---|
| EVENT DESCRIPTION |
|---|
| THE CONSUMER PURCHASED AN ADHESIVE BODY BRA KIT WHICH ALSO CONTAINED PROTECTIVE DRESSING WIPE. THE CUSTOMER INDICATED THAT REDNESS AND BLISTERING OCCURRED AFTER THE REMOVAL OF BRA. DURING USE OF PRODUCT, CUSTOMER FELT DISCOMFORT IN SUBJECT AREA. THE BRA WAS LEFT ON FOR 4 HRS. THE DIRECTIONS OF USAGE CALLS FOR APPLYING WIPE TO DRY SURFACE AND THEN APPLYING ADHESIVE BRA. |
