MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-23 for RETRACTOR * 88-1088 manufactured by Snowden-pencer, Inc..
[57149]
There were two incidents of burns, discovered after surgery (3/21/97 and 4/17/97). The first incident occurred when the retractor and light cord were separated and left on the pt inadvertently. In the second incident, the connection between the retractor and the light cord became very hot and caused a half centimeter burn on the pt. According to the rptr, the connection should not get hot. Both pts were treated with ointment and bandage. No scarring occurred.
Patient Sequence No: 1, Text Type: D, B5
[6077354]
There were two incidents of burns, discovered after surgery. The first incident occurred when the retractor and light cord were separated and left on the pt inadvertently. In the second incident, he connection between the retractor and the light cord became very hot and caused a half centimeter burn on the pt. According to the rptr, the connection should not get hot. Both pts were treated with ointment and bandage. No scarring occurred.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | MW1011181 |
| MDR Report Key | 85997 |
| Date Received | 1997-04-23 |
| Date of Report | 1997-04-23 |
| Date of Event | 1997-03-21 |
| Date Added to Maude | 1997-04-25 |
| 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 | RETRACTOR |
| Generic Name | RETRACTOR |
| Product Code | HNI |
| Date Received | 1997-04-23 |
| Model Number | * |
| Catalog Number | 88-1088 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85199 |
| Manufacturer | SNOWDEN-PENCER, INC. |
| Manufacturer Address | 5175 SOUTH ROYAL DR. TUCKER GA 30084 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-23 |
| 2 | 0 | 1. Other | 1997-04-23 |