FDA Adverse Event
Death
Summary report: N
TUCKER MCLEAN FORCEPS
MDR report key: 132549
·
Received November 14, 1997
Report
- Report Number
- 132549
- Event Type
- Death
- Date Received
- November 14, 1997
- Date of Event
- November 2, 1997
- Report Date
- November 13, 1997
- Manufacturer
- PILLING SURGICAL INSTRUMENTS
- Product Code
- HDA
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
USE OF FORCEPS INDICATED AS MOTHER UNABLE TO PUSH EFFECTIVELY TO DELIVER INFANT. INFANT IN BIRTH CANAL AND HAVING DECELERATIONS WITH CONTRACTIONS. BABY "FACE UP". TUCKER MCLEAN FORCEPS INSERTED WITH DIFFICULTY. AT FIRST ATTEMPT, FORCEPS SLIPPED. INFANT EXTRACTED WITH SECOND ATTEMPT (WITH SHORT SIMPSONS). NEONATAL DEATH RESULTED AND PHYSICIAN TOLD FAMILY THAT HE HAD FRACTURED THE BABY'S SKULL WITH THE FIRST ATTEMPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUCKER MCLEAN FORCEPS | FORCEPS | HDA | PILLING SURGICAL INSTRUMENTS | * | CC4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DAY | Death |