MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-07-24 for CUSTOM PAK manufactured by Alcon Laboratories, Inc..
[18328119]
User facility reports skin drape was too sticky and pulled off some of the pt's skin. Neosporin was applied and the abrasion resolved. No serious injury was reported however, the reporter states that if this event were to recur it could result in a serious innury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-1998-00004 |
| MDR Report Key | 178955 |
| Report Source | 06 |
| Date Received | 1998-07-24 |
| Date of Report | 1998-06-23 |
| Date of Event | 1998-04-15 |
| Date Facility Aware | 1998-04-15 |
| Date Mfgr Received | 1998-06-23 |
| Date Added to Maude | 1998-07-29 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM PAK |
| Generic Name | SURGICAL PAK |
| Product Code | KXX |
| Date Received | 1998-07-24 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | WB66635 |
| ID Number | N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174005 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 2650 WEST BELLFORT HOUSTON TX 77054 US |
| Baseline Brand Name | CUSTOM PAK |
| Baseline Generic Name | SURGICAL PAK |
| Baseline Model No | NA |
| Baseline Catalog No | NA |
| Baseline ID | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-24 |