MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-11-16 for COBAS? PCR FEMALE SWAB SAMPLE KIT 05170516190 manufactured by Roche Molecular Systems, Inc.
[59999695]
As the physician was using the cobas female pcr swab for off-label sample collection types, roche instructed the customer to utilize the cobas? Pcr swabs for on-label sample collection per the product labeling. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59999696]
A customer from (b)(6) reported that a patient was admitted to the hospital to remove a broken cobas pcr female swab from their stomach. The cobas pcr female swab was used in an off-label manner to collect a throat swab from the patient in a physician's office. The intended use of the cobas pcr female swab sample kit is to collect and transport endocervical and vaginal swab specimens. During the collection of the throat swab, the cobas pcr female swab broke in the patient's mouth and the physician was unable to retrieve it. The cobas pcr female swab was then swallowed. The patient went to the hospital where they had to under-go an endoscopy to have the cobas pcr female swab removed from their stomach. A second endoscopy was performed and indicated that there was no damage to the patient's esophagus or stomach as a result of this situation. Overall, the patient has been reported as being "fine" and no medication was administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2016-00019 |
| MDR Report Key | 6105627 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-11-16 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-10-31 |
| Date Mfgr Received | 2016-11-01 |
| Date Added to Maude | 2016-11-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA TIMOTHY BLAIR |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537918 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS? PCR FEMALE SWAB SAMPLE KIT |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2016-11-16 |
| Model Number | NA |
| Catalog Number | 05170516190 |
| Lot Number | X04095 |
| ID Number | NA |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-16 |