MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-16 for HOLLISTER manufactured by Hollister.
[745119]
Pouch broke at the seam after 4 hours of use. It's been happening once a year within 32 years of usage. Each time, he has received a new bag through mail. Patient was frustrated because of this ongoing issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004968 |
| MDR Report Key | 980054 |
| Date Received | 2008-01-16 |
| Date of Report | 2008-01-16 |
| Date Added to Maude | 2008-01-23 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER |
| Generic Name | DRAINAGE POUCH/BAG |
| Product Code | FON |
| Date Received | 2008-01-16 |
| Lot Number | 70162 |
| ID Number | REF# 3273 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 949134 |
| Manufacturer | HOLLISTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-16 |