MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-24 for DRAIN, SUCTION, 15FR, ROUND SU130-1323 manufactured by Allegiance Healthcare Corp..
[17112041]
Account states a 58yr old developed an infection and required re-admission and surgery for removal of a retained portion of a jackson-pratt drain. Initial abdominal surgery with insertion of the drain was 1999. Drain initially removed in physicians office after pt was discharged. Physician unaware that a portion of the drain had broken off and remained in the pt. Pt developed an abdominal wall infection which prompted exploration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1999-00174 |
| MDR Report Key | 231359 |
| Report Source | 05 |
| Date Received | 1999-06-24 |
| Date of Report | 1999-05-25 |
| Date of Event | 1999-04-29 |
| Date Mfgr Received | 1999-05-25 |
| Date Added to Maude | 1999-07-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAIN, SUCTION, 15FR, ROUND |
| Generic Name | WOUND DRAIN |
| Product Code | JCY |
| Date Received | 1999-06-24 |
| Model Number | SU130-1323 |
| Catalog Number | SU130-1323 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 224254 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | DRAIN, SUCTION, 15FR, ROUND |
| Baseline Generic Name | WOUND DRAIN |
| Baseline Model No | SU130-1323 |
| Baseline Catalog No | SU130-1323 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-06-24 |