MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-03 for DRAINAGE FECAL INCONTINENCE COLLECTOR 9821 manufactured by Hollister.
[6741]
Fecal incontinence collector applied 9/29/94. Removed because of leakage. Pt now has partial-thickness red, moist, open areas: left buttock 2. 5 x 1. 5 cm and right buttock 11 x 1-3. 5 cm. Rptr applied device. Staff removed device. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9117 |
| MDR Report Key | 9117 |
| Date Received | 1994-10-03 |
| Date of Report | 1994-09-30 |
| Date of Event | 1994-07-19 |
| Date Facility Aware | 1994-07-19 |
| Report Date | 1994-09-30 |
| Date Reported to FDA | 1994-09-30 |
| Date Reported to Mfgr | 1994-07-20 |
| Date Added to Maude | 1994-11-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINAGE FECAL INCONTINENCE COLLECTOR |
| Generic Name | DRAINAGE FECAL INCONTINENCE COLLECTOR |
| Product Code | KGY |
| Date Received | 1994-10-03 |
| Model Number | 9821 |
| Catalog Number | 9821 |
| Lot Number | 4D222 |
| ID Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8777 |
| Manufacturer | HOLLISTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-10-03 |