MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-02 for SKIN MARKING PEN * manufactured by Hospital Marketing Services, Co, Inc..
[55570]
There have been numerous complaints in the past week by the surgeons in the operating room concerning the new skin marking pens facility has been using. These pens do not mark adequately on the skin even though their expiration date, is not unitl 1998 and even though they don't seem to be dry. All the surgeons agree that the previous pens they were using performed much better. Old pens were made by another co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001864 |
| MDR Report Key | 88201 |
| Date Received | 1997-05-02 |
| Date of Report | 1997-05-02 |
| Date Added to Maude | 1997-05-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN MARKING PEN |
| Generic Name | SKIN MARKING PEN |
| Product Code | HRP |
| Date Received | 1997-05-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1551 |
| ID Number | M97093013,TD70033,WK4FV17076Q0 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 87316 |
| Manufacturer | HOSPITAL MARKETING SERVICES, CO, INC. |
| Manufacturer Address | INDUSTRIAL PARK P.O. BOX 184 U.C. NAUGATUCK CT 06770 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-02 |