MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-23 for PATTERSON DENTAL 1505 * manufactured by *.
[229067]
Add'l info rec'd from mfr 2/14/02: the product referenced in medwatch form, ref number 1023497 is mfg for patterson dental co by dentafix uk ltd, units 11, 12, 13 helix, business park wilton rd, surrey, england. Patterson is merely a distributor of the product, and does not alter, change or repackage the product. They believe primary responsibility rests with the mfr. As a general procedure, however, whenever they receive a report involving product failure, they investigate the incident and attempt to retrieve the product and have it tested. Due to the anonymity of the rptr, a full investigation of this matter, including retrieval of the product for testing purposes has not been possible.
Patient Sequence No: 1, Text Type: D, B5
[288031]
Add'l info received from mfr 12-28-2001: patterson dental compant does not mfr this particular instrument. This instrument is manufactured by denfix uk ltd units 11,12,13 helix, business park wilton road, surrey, england. If a sample of the forceps was submitted they would like to retrieve them for the mfr to perform testing.
Patient Sequence No: 1, Text Type: D, B5
[288166]
Add'l info received from mfr 4/15/02: the product referenced in medwatch from is manufactured for patterson dental company by dentafix uk ltd, units 11,12,13 helix, business park wilton road, surrey, england. Patterson is merely a distributor of the product, and does not alter, change or repackage the product. They believe primary responsibility rests with the mfr. As a general procedure, however, whenever co receives a report involving product failure, the co investigates the incident and attempts to retrieve the product and have it tested. Due to the anonymity of the reporter, a full investigation of this matter, including retrieval of the product for testing purposes has not been possible.
Patient Sequence No: 1, Text Type: D, B5
[19783744]
Rptr was extracting tooth # 14 on a severely developmentally disabled child. Rptr was using patterson dental brand of forceps #1505. As rptr put the forceps on the tooth the beak of the forceps broke and fell down the pt's throat. Rptr immediately grabbed the child and held them so their head was the lowest part of their body. The broken portion was coughed out. A second 1505 broke in the same spot while being cleaned. A third forceps of the same size and brand was reported to have broken at one of rptr's offices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023497 |
| MDR Report Key | 362834 |
| Date Received | 2001-11-23 |
| Date of Report | 2001-11-01 |
| Date of Event | 2001-09-01 |
| Date Added to Maude | 2001-12-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATTERSON DENTAL |
| Generic Name | DENTAL FORCEPS #1505 |
| Product Code | EMG |
| Date Received | 2001-11-23 |
| Model Number | 1505 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 351972 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-23 |