MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-01-28 for INTRAN PLUS IUP-400 manufactured by .
[89307]
The iupc, intran plus was placed at 1013 am by the physician. At 1014 am fht deceleration down to 90's was noted and did not respond to position changes, o2 administration, or increased iv fluid. At 1018 fht deceleration continued down to 40's-60's. The pt was prepared for an emergency c-section and taken to the or at 1021 am. A flaccid, blood covered infant was delivered. There was a copious amount of blood from the airway. The resuscitation efforts were unsuccessful. The pathology report indicated a slight laceration in the middle of the placenta. The proximal end of the umbilical cord appeared ragged and torn. The surgeon recorded that the cord broke when attempting to deliver the placenta. The report also stated diffuse recent intra-alveolar hemorrage of right and left lungs. Med device involvement was not confirmed until autopsy report was completed 01-15-98. This accounts for delay in reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718873-1998-00002 |
| MDR Report Key | 146393 |
| Report Source | 06 |
| Date Received | 1998-01-28 |
| Date of Report | 1998-01-22 |
| Date of Event | 1997-12-09 |
| Date Mfgr Received | 1997-12-19 |
| Date Added to Maude | 1998-02-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAN PLUS |
| Product Code | KXO |
| Date Received | 1998-01-28 |
| Model Number | NA |
| Catalog Number | IUP-400 |
| Lot Number | UNK |
| ID Number | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 140760 |
| Baseline Brand Name | INTRAN PLUS |
| Baseline Generic Name | IUPC |
| Baseline Model No | IUP-400 |
| Baseline Catalog No | IUP-400 |
| Baseline ID | NA |
| Baseline Device Family | INTRAN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955443 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-28 |