MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-07 for URINE SPECIMEN COLLECTOR PEDI BAG 05-0531 manufactured by Mark Clark Industries.
[17093]
Urine specimen collector bag was used to obtain a specimen from a newborn. During the time the specimen bag was in place the pt developed erythematous irritation to the perineum to the degree that it would be considered a high risk potential for an infectious process. The pt was discharged to home with perineal instructions given to the parents and all urine specimen bags were pulled and returned to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24042 |
| MDR Report Key | 24042 |
| Date Received | 1995-07-07 |
| Date of Report | 1995-03-14 |
| Date of Event | 1995-03-05 |
| Date Facility Aware | 1995-03-05 |
| Report Date | 1995-03-14 |
| Date Reported to Mfgr | 1995-03-16 |
| Date Added to Maude | 1995-08-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINE SPECIMEN COLLECTOR |
| Generic Name | URINE SPECIMEN COLLECTOR |
| Product Code | FOC |
| Date Received | 1995-07-07 |
| Model Number | PEDI BAG |
| Catalog Number | 05-0531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 24379 |
| Manufacturer | MARK CLARK INDUSTRIES |
| Manufacturer Address | TOPEKA KS 666142074 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-07 |