FDA Adverse Event
Other
Summary report: N
NU GAUZE PACKING STRIP/IODOFORM
MDR report key: 179183
·
Received July 28, 1998
Report
- Report Number
- 1618732-1998-00164
- Event Type
- Other
- Date Received
- July 28, 1998
- Date of Event
- June 1, 1998
- Report Date
- June 30, 1998
- Manufacturer
- JOHNSON & JOHNSON MEDICAL, INC.
- Product Code
- GEL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CONSUMER STATES THAT HIS WIFE HAD A LUMP SURGICALLY REMOVED FROM HER BREAST ABOUT TWO MONTHS AGO AND THE WOUND WAS LEFT OPEN. THE WOUND WAS PACKED WITH A PACKING STRIP. HIS WIFE STATES THERE WAS A BURNING SENSATION. HE STATED THAT A HEMATOMA DEVELOPED WHICH REQUIRED DEBRIDEMENT. THE PACKING STRIP WAS SWITCHED TO A DIFFERENT TYPE AND THE WOUND IS DOING BETTER. HE IS UNSURE OF ANY PERMANENT DAMAGE OR INJURY TO THE WOUND. HIS WIFE IS ALLERGIC TO IODINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NU GAUZE PACKING STRIP/IODOFORM | GAUZE, SPONGE, MEDICATED | GEL | JOHNSON & JOHNSON MEDICAL, INC. | NA | 599-56 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |