MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-09-29 for MALLINCKRODT 90042 manufactured by Covidien/formerly Tyco Healthcare.
[1834738]
Covidien received on 08/30/2010, (b)(4). It was reported that "during the esophagogastroduodenoscopy (egd) portion of a gastric pacemaker implantation case, the temperature probe of the esophageal stethoscope became dislodged distally down into the stomach. Upon extraction of the temperature probe, the proximal tip became lodged in the left lateral wall of the cervical esophagus just below the upper esophageal sphincter. The retained tip was removed successfully, but a small laceration of the left lateral cervical esophageal wall did occur. " the patient's stay in the hospital was extended, she was given additional antibiotics as well.
Patient Sequence No: 1, Text Type: D, B5
[8691502]
The lot number is unknown. We are following up with the facility for additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2010-01222 |
| MDR Report Key | 1872641 |
| Report Source | 06 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-08-30 |
| Date of Event | 2010-07-22 |
| Date Mfgr Received | 2010-08-30 |
| Date Added to Maude | 2010-10-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HOLLY GOMES, SUPERVISOR |
| Manufacturer Street | 5870 STONERIDGE DRIVE SUITE 6 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634612 |
| Manufacturer G1 | COVIDIEN/FORMERLY TYCOHEALTHCARE |
| Manufacturer Street | AVENIDA HENEQUEN 1181 PARQUE INDUST SALVARCAR |
| Manufacturer City | CD. JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLINCKRODT |
| Generic Name | ESOPHAGEAL STETHOSCOPE W/TEMP SENSO |
| Product Code | BZW |
| Date Received | 2010-09-29 |
| Catalog Number | 90042 |
| ID Number | RX201009-2297 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/FORMERLY TYCO HEALTHCARE |
| Manufacturer Address | AVENIDA HENEQUEN CD. JUAREZ, CHIHUAHUA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-09-29 |